STEFNE: Fasting on Newly Diagnosed Breast Cancer

• Sponsor: Western Regional Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02379585
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arms: 2
• Actual Duration (Months): 30.9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This study is to see how safe the use of short-term fasting is in breast cancer patients who will receive chemotherapy before undergoing surgery and to examine if the use of short-term fasting will decrease the side effects of chemotherapy and how much a tumor shrinks while receiving chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
HER2-positive Breast Cancer	Drug: Doxorubicin; Drug: cyclophosphamide; Drug: paclitaxel; Drug: docetaxel; Drug: Trastuzumab; Drug: Pertuzumab	Phase 1/Phase 2

Detailed Description

Patients will fast 24 hours before and 24 hours after the administration of chemotherapy which will consist of doxorubicin plus cyclophosphamide every 2 weeks for four cycles followed by paclitaxel every 2 weeks for four cycles (dose-dense AC + T) or docetaxel (T) every 3 weeks for four cycles. Trastuzumab (H) and Pertuzumab (P) will be given concurrently with docetaxel for a total of 4 cycles before surgery. For patients who do not achieve pathological complete remission (pCR), adjuvant chemotherapy with doxorubicin (A) plus cyclophosphamide (C) every 3 weeks for four cycles will be given, followed by trastuzumab every 3 weeks to complete 1 year of treatment. For patients with pCR, only trastuzumab every 3 weeks will be given adjuvantly to complete 1 year of treatment (TPH + AC).

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study of Short-term Fasting on Neoadjuvant Chemotherapy in Patients With Newly Diagnosed Breast Cancer (STEFNE Study)
• Actual Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: HER2 negative breast cancer Doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three to six weeks after completing the last cycle of paclitaxel.	Drug: Doxorubicin; doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 2 weeks for four cycles followed by paclitaxel (T) 75 mg/m2 every 2 weeks for four cycles (dose-dense AC + T).20; Other Names: (dose-dense AC + T).2 ; Drug: cyclophosphamide; doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 2 weeks for four cycles followed by paclitaxel (T) 75 mg/m2 every 2 weeks for four cycles (dose-dense AC + T).20; Other Names: (dose-dense AC + T).20 ; Drug: paclitaxel; For patients with HER2 negative breast cancer: doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 2 weeks for four cycles followed by paclitaxel (T) 75 mg/m2 every 2 weeks for four cycles (dose-dense AC + T).20; Other Names: (dose-dense AC + T).20
Active Comparator: HER2 positive breast cancer Docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles. Pegfilgrastim after docetaxel. Surgery three to six weeks after completing the last docatexel. If additional chemotherapy is needed patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle then trastuzumab for one year	Drug: docetaxel; For patients with HER2 positive breast cancer: docetaxel (T) 75 mg/m2 every 3 weeks for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent 3 cycles), Pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery. For patients who do not achieve pCR, adjuvant chemotherapy with doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 3 weeks for four cycles will be given, followed by trastuzumab 6 mg/kg every 3 weeks to complete 1 year of treatment. For patients with pCR, only trastuzumab 6 mg/kg every 3 weeks will be given adjuvantly to complete 1 year of treatment (TPH + AC).21; Other Names: (TPH + AC).21 ; Drug: Trastuzumab; docetaxel (T) 75 mg/m2 every 3 weeks for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent 3 cycles), Pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery. For patients who do not achieve pCR, adjuvant chemotherapy with doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 3 weeks for four cycles will be given, followed by trastuzumab 6 mg/kg every 3 weeks to complete 1 year of treatment. For patients with pCR, only trastuzumab 6 mg/kg every 3 weeks will be given adjuvantly to complete 1 year of treatment (TPH + AC).21; Other Names: (TPH + AC).21 ; Drug: Pertuzumab; docetaxel (T) 75 mg/m2 every 3 weeks for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent 3 cycles), Pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery. For patients who do not achieve pCR, adjuvant chemotherapy with doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 3 weeks for four cycles will be given, followed by trastuzumab 6 mg/kg every 3 weeks to complete 1 year of treatment. For patients with pCR, only trastuzumab 6 mg/kg every 3 weeks will be given adjuvantly to complete 1 year of treatment (TPH + AC).21; Other Names: (TPH + AC).21

Outcome Measures

Primary Outcome Measures

1. Pathological Response Rate at the Time of Surgery or at the Time of Biopsy [4-6 cycles (up to 12 weeks)]

   Evaluate pathological complete remission rate at the time of surgery, or partial pathological response rate (defined as residual invasive disease of 1cm) at the time of surgery or at the time of biopsy upon completion of planned chemotherapy.

Secondary Outcome Measures

1. Fasting on the Toxicity of Neoadjuvant Chemotherapyaccording to the NCI [4-6 cycles (up to 12 weeks)]

   The effect of short-term fasting on the toxicity of neoadjuvant chemotherapy in breast cancer patients according to the NCI common toxicity criteria (Version 4.03)

2. Pathological Response Rate at the Time of Surgery or Time of Biopsy Upon Completion of Planned Chemotherapy [4-6 cycles]

   To evaluate pathological complete remission rate (defined as disappearance of all invasive tumor in the breast; ypT0-is) at the time of surgery, or partial pathological response rate (defined as residual invasive disease of 1cm, ypT1a-b) at the time of surgery or at the time of biopsy upon completion of planned chemotherapy for triple-negative breast cancer.

3. Insulin Abnormalities [4-6 cycles (up to 12 weeks)]

   Changes in plasma insulin abnormalities after short-term fasting and chemotherapy

4. Biomarker Changes Before and After Chemotherapy [4-6 cycles (up to 12 weeks)]

   Biomarker changes in breast cancer (biopsy or residual tumor) before and after neoadjuvant chemotherapy

5. Nutritional Assessment Before and After Neoadjuvant Chemotherapy [4-6 cycles (up to 12 weeks)]

   Nutritional status assessment with Patient Generated Subjective Global Assessment (aPG-SGA) before and after neoadjuvant chemotherapy

6. Glucose After Fasting and Chemotherapy [4-6 cycles (up to 12 weeks)]

   To investigate changes in glucose after short-term fasting and chemotherapy

7. Changes in Insulin-like Growth Factor-1 [4-6 cycles (up to 12 weeks)]

   To investigate changes in Insulin-like growth factor-1 (IGF1) after short-term fasting and chemotherapy

8. Plasma Blood-based Tumor-related Abnormalities in DNA [4-6 cycles (up to 12 weeks)]

   To investigate changes in plasma blood-based tumor-related abnormalities in DNA after short-term fasting and chemotherapy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients ≥ 18 years of age with histologically, and radiographically confirmed non-metastatic breast cancer with minimal tumor size over 1 cm (≥T1c lesion) to receive neoadjuvant chemotherapy recommended by the treating physician

• For estrogen receptor (ER) strongly positive, human epithelial receptor (HER2) negative breast cancer, Oncotype Dx study is required. Patients with low recurrence score will be excluded in the study.

• Eastern Cooperative Oncology Group (ECOG) performance status score < 1

• Absolute neutrophil count > 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.5 g/dL

• Serum creatinine ≤1.5 times the upper limit of the normal range, total bilirubin ≤ 1.5 X ULN (≤ 3 mg/dL if clinically diagnosed with Gilbert syndrome) AST/ALT ≤ 2.5 X ULN (AST/ALT ≤ 5X ULN if clinically diagnosed with Gilbert syndrome)

• Willing to provide blood samples for correlative research purposes

• Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable contraceptive method (abstinence, oral contraceptive or double barrier method) for the duration of the study and for 30 days following the last dose of study drug, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial.

Exclusion Criteria:

1. Uncontrolled cardiac disease, such as angina, hypertension or significant arrhythmias, congestive heart failure (NYHA grade 2 or more or LVEF < 40% on any prior assessment). Note: Assessment of LVEF is done before and after anthracycline-based or trastuzumab-based chemotherapy as standard of care

2. Pregnant or lactating females

3. Known history of diabetes mellitus. If screening fasting glucose is ≥126 mg/dL, an HbA1C must be < 6.5%.

4. History of syncope with calorie restriction in the past

5. Body mass index (BMI) < 19 kg/m2

6. Clinical signs or symptoms of GI obstruction and/or requirement for parenteral hydration or nutrition

7. Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements

8. Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements

9. Any other medical comorbidity that requires daily medication(s) that may not be safely taken without food.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Western Regional Medical Center	Goodyear	Arizona	United States	85338

Sponsors and Collaborators

• Western Regional Medical Center

Investigators

• Study Director: Jordan Waypa, FNP, Research Director

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Western Regional Medical Center
• ClinicalTrials.gov Identifier: NCT02379585
• Other Study ID Numbers: 1145332
• First Posted: Mar 5, 2015
• Last Update Posted: Apr 24, 2018
• Last Verified: Mar 1, 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Breast Neoplasms; Paclitaxel; Docetaxel; Cyclophosphamide; Doxorubicin; Trastuzumab; Pertuzumab

Study Results

Participant Flow

Arm/Group Title	Diagnosed With HER2 Negative Breast Cancer	Diagnosed With HER2 Positive Breast Cancer
Arm/Group Description	Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three-six weeks after completing the last cycle of paclitaxel. Doxorubicin: For patients with HER2 negative breast cancer: doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 2 weeks for four cycles followed by paclitaxel (T) 75 mg/m2 every 2 weeks for four cycles (dose-dense AC + T).20 cyclophosphamide: For patients with HER2 negative breast cancer: doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 2 weeks for four cycles followed by paclitaxel (T) 75 mg/m2 every 2 weeks for four cycles (dose-dense AC + T).20 paclitaxel: For patients with HER2 negative breast cancer: doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 2 weeks for four cycles followed by paclitaxel (	will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year docetaxel: For patients with HER2 positive breast cancer: docetaxel 75 mg/m2 every 3 weeks for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent 3 cycles), Pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles be
Period Title: Overall Study
STARTED	3	5
COMPLETED	0	0
NOT COMPLETED	3	5

Baseline Characteristics

Arm/Group Title	Diagnosed With HER2 Negative Breast Cancer	Diagnosed With HER2 Positive Breast Cancer	Total
Arm/Group Description	Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three to six weeks after completing the last cycle of paclitaxel.	will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year	Total of all reporting groups
Overall Participants	0	0	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male () []
Female
Male
Region of Enrollment () []

Outcome Measures

1. Primary Outcome

Title	Pathological Response Rate at the Time of Surgery or at the Time of Biopsy
Description	Evaluate pathological complete remission rate at the time of surgery, or partial pathological response rate (defined as residual invasive disease of 1cm) at the time of surgery or at the time of biopsy upon completion of planned chemotherapy.
Time Frame	4-6 cycles (up to 12 weeks)

Outcome Measure Data

Analysis Population Description

Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information. After much effort, results were not able to be retained.

Arm/Group Title	Diagnosed With HER2 Negative Breast Cancer	Diagnosed With HER2 Positive Breast Cancer
Arm/Group Description	Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three to six weeks after completing the last cycle of paclitaxel.	will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year
Measure Participants	0	0

2. Secondary Outcome

Title	Fasting on the Toxicity of Neoadjuvant Chemotherapyaccording to the NCI
Description	The effect of short-term fasting on the toxicity of neoadjuvant chemotherapy in breast cancer patients according to the NCI common toxicity criteria (Version 4.03)
Time Frame	4-6 cycles (up to 12 weeks)

Outcome Measure Data

Analysis Population Description

Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information."After much effort, results were not able to be retained.

Arm/Group Title	Diagnosed With HER2 Negative Breast Cancer	Diagnosed With HER2 Positive Breast Cancer
Arm/Group Description	Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles.	Will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days).
Measure Participants	0	0

3. Secondary Outcome

Title	Pathological Response Rate at the Time of Surgery or Time of Biopsy Upon Completion of Planned Chemotherapy
Description	To evaluate pathological complete remission rate (defined as disappearance of all invasive tumor in the breast; ypT0-is) at the time of surgery, or partial pathological response rate (defined as residual invasive disease of 1cm, ypT1a-b) at the time of surgery or at the time of biopsy upon completion of planned chemotherapy for triple-negative breast cancer.
Time Frame	4-6 cycles

Outcome Measure Data

Analysis Population Description

Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information."After much effort, results were not able to be retained.

Arm/Group Title	Diagnosed With HER2 Negative Breast Cancer	Diagnosed With HER2 Positive Breast Cancer
Arm/Group Description	Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three to six weeks after completing the last cycle of paclitaxel.	Will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year
Measure Participants	0	0

4. Secondary Outcome

Title	Insulin Abnormalities
Description	Changes in plasma insulin abnormalities after short-term fasting and chemotherapy
Time Frame	4-6 cycles (up to 12 weeks)

Outcome Measure Data

Analysis Population Description

Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information."After much effort, results were not able to be retained.

Arm/Group Title	Diagnosed With HER2 Negative Breast Cancer	Diagnosed With HER2 Positive Breast Cancer
Arm/Group Description	Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three to six weeks after completing the last cycle of paclitaxel.	Will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year
Measure Participants	0	0

5. Secondary Outcome

Title	Biomarker Changes Before and After Chemotherapy
Description	Biomarker changes in breast cancer (biopsy or residual tumor) before and after neoadjuvant chemotherapy
Time Frame	4-6 cycles (up to 12 weeks)

Outcome Measure Data

Analysis Population Description

Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information."After much effort, results were not able to be retained.

Arm/Group Title	Diagnosed With HER2 Negative Breast Cancer	Diagnosed With HER2 Positive Breast Cancer
Arm/Group Description	Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three to six weeks after completing the last cycle of paclitaxel.	Will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year
Measure Participants	0	0

6. Secondary Outcome

Title	Nutritional Assessment Before and After Neoadjuvant Chemotherapy
Description	Nutritional status assessment with Patient Generated Subjective Global Assessment (aPG-SGA) before and after neoadjuvant chemotherapy
Time Frame	4-6 cycles (up to 12 weeks)

Outcome Measure Data

Analysis Population Description

Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information."After much effort, results were not able to be retained.

Arm/Group Title	Diagnosed With HER2 Negative Breast Cancer	Diagnosed With HER2 Positive Breast Cancer
Arm/Group Description	Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three to six weeks after completing the last cycle of paclitaxel.	Will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year
Measure Participants	0	0

7. Secondary Outcome

Title	Glucose After Fasting and Chemotherapy
Description	To investigate changes in glucose after short-term fasting and chemotherapy
Time Frame	4-6 cycles (up to 12 weeks)

Outcome Measure Data

Analysis Population Description

Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information."After much effort, results were not able to be retained.

Arm/Group Title	Diagnosed With HER2 Negative Breast Cancer	Diagnosed With HER2 Positive Breast Cancer
Arm/Group Description	Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three to six weeks after completing the last cycle of paclitaxel.	Will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year
Measure Participants	0	0

8. Secondary Outcome

Title	Changes in Insulin-like Growth Factor-1
Description	To investigate changes in Insulin-like growth factor-1 (IGF1) after short-term fasting and chemotherapy
Time Frame	4-6 cycles (up to 12 weeks)

Outcome Measure Data

Analysis Population Description

Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information."After much effort, results were not able to be retained.

Arm/Group Title	Diagnosed With HER2 Negative Breast Cancer	Diagnosed With HER2 Positive Breast Cancer
Arm/Group Description	Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three to six weeks after completing the last cycle of paclitaxel.	Will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year
Measure Participants	0	0

9. Secondary Outcome

Title	Plasma Blood-based Tumor-related Abnormalities in DNA
Description	To investigate changes in plasma blood-based tumor-related abnormalities in DNA after short-term fasting and chemotherapy
Time Frame	4-6 cycles (up to 12 weeks)

Outcome Measure Data

Analysis Population Description

Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information."After much effort, results were not able to be retained.

Arm/Group Title	Diagnosed With HER2 Negative Breast Cancer	Diagnosed With HER2 Positive Breast Cancer
Arm/Group Description	Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three to six weeks after completing the last cycle of paclitaxel.	Will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year
Measure Participants	0	0

Adverse Events

Time Frame	NA Data was not collected
Arm/Group Title	Diagnosed With HER2 Negative Breast Cancer		Diagnosed With HER2 Positive Breast Cancer
Arm/Group Description	Patients will receive doxorubicin and cyclophosphamide every two weeks for four cycles (one cycle is defined as 14 days). After completing fourth cycle, they will receive paclitaxel every two weeks for an additional four cycles. The appropriate surgery will be done three to six weeks after completing the last cycle of paclitaxel. 0		will receive docetaxel, trastuzumab, and pertuzumab every three weeks for four cycles (one cycle is defined as 21 days). An injection of pegfilgrastim will be administered after chemotherapy with docetaxel. The appropriate surgery will be done three to six weeks after completing the last cycle of docatexel. If the study doctor determines that additional chemotherapy is needed (based on tumor shrinkage), patients will receive both doxorubicin and cyclophosphamide every three weeks for four cycles and after the fourth cycle you will receive trastuzumab every three weeks for one year or patients will receive trastuzumab alone every three weeks for up to one year
All Cause Mortality
	Diagnosed With HER2 Negative Breast Cancer		Diagnosed With HER2 Positive Breast Cancer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Diagnosed With HER2 Negative Breast Cancer		Diagnosed With HER2 Positive Breast Cancer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Diagnosed With HER2 Negative Breast Cancer		Diagnosed With HER2 Positive Breast Cancer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.