Weekly Gemcitabine, Epirubicin, and Docetaxel in Locally Advanced or Inflammatory Breast Cancer

• Sponsor: SCRI Development Innovations, LLC (Other)
• Overall Status: Completed
• CT.gov ID: NCT00193050
• Collaborator: Pharmacia and Upjohn (Industry), Eli Lilly and Company (Industry), Aventis Pharmaceuticals (Industry)
• Enrollment: 110
• Arm: 1
• Duration (Months): 88

Study Details

Study Description

Brief Summary

Treatment strategies that include induction chemotherapy have several potential advantages:

early initiation of systemic chemotherapy, in vivo assessment of response, and down-staging of both the primary tumor and regional lymphatic metastases, making breast conservation an option for many. The aim of the present study is to determine the efficacy and toxicity of induction combination chemotherapy with the triplet, gemcitabine, epirubicin, and docetaxel, in patients with locally advanced or inflammatory breast cancer. Clearly, it is in the upfront treatment as well as in the adjuvant treatment of breast cancer, that effective new agents and combination of agents are likely to have the greatest potential impact.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Gemcitabine; Drug: Epirubicin; Drug: Docetaxel	Phase 2

Detailed Description

Upon determination of eligibility, all patients will be receive:

Gemcitabine + Epirubicin + Docetaxel

Study Design

• Study Type: Interventional
• Actual Enrollment: 110 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Trial of Induction Chemotherapy With Weekly Gemcitabine, Epirubicin, Docetaxel as Primary Treatment of Locally Advanced or Inflammatory Breast Cancer Patients
• Study Start Date: Nov 1, 2001
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Intervention In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed. After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals. After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines.

Drug: Gemcitabine; Gemcitabine; Other Names: Gemzar ; Drug: Epirubicin; Epirubicin; Other Names: Ellence ; Drug: Docetaxel; Docetaxel; Other Names: Taxotere

Outcome Measures

Primary Outcome Measures

1. Pathologic Complete Response (pCR) [18 Months]

   For the purpose of this study, a Pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0). Residual ductal or lobular carcinoma in situ was not considered in pCR assessments. Percentage of participants who experienced pCR is reported.

Secondary Outcome Measures

1. Time to Treatment Failure (TTF) [69 months]

   Time to Treatment Failure (TTF) is defined as the minimum of the time from first date of treatment to the either of the following dates: disease progression date (RECIST or clinical) death date treatment discontinuation

2. Overall Survival (OS) [48 months]

   Number of participants that are alive at 48th months

Eligibility Criteria

Criteria

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

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

• Adenocarcinoma of the breast confirmed by biopsy

• Female Patients >18 years of age

• Normal cardiac function

• Ability to perform activities of daily living with minimal assistance

• Chemotherapy naïve or have received prior chemotherapy > 5 years ago

• Adequate bone marrow, liver and kidney function

• Be informed of the investigational nature of this study

• Sign an informed consent form

• Sentinel lymph node and/or axillary dissection prior to enrollment

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

• Life expectancy of < than 6 months

• History of significant heart disease

• Prior chemotherapy or hormonal therapy

• Concurrent Trastuzumab therapy

• History of significant psychiatric disorders

• History of active uncontrolled infection

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• SCRI Development Innovations, LLC
• Pharmacia and Upjohn
• Eli Lilly and Company
• Aventis Pharmaceuticals

Investigators

• Principal Investigator: Denise A. Yardley, MD, SCRI Development Innovations, LLC

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Published article in Clinical Breast Cancer

Publications

None provided.

• Responsible Party: SCRI Development Innovations, LLC
• ClinicalTrials.gov Identifier: NCT00193050
• Other Study ID Numbers: SCRI BRE 51
• First Posted: Sep 19, 2005
• Last Update Posted: Oct 26, 2021
• Last Verified: Oct 1, 2021

• Additional relevant MeSH terms: Breast Neoplasms; Inflammatory Breast Neoplasms; Gemcitabine; Docetaxel; Epirubicin

Study Results

Participant Flow

Arm/Group Title	Intervention
Arm/Group Description	In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed. After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals. After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines.
Period Title: Neoadjuvant Treatment
STARTED	110
COMPLETED	101
NOT COMPLETED	9
Period Title: Neoadjuvant Treatment
STARTED	103
COMPLETED	103
NOT COMPLETED	0
Period Title: Neoadjuvant Treatment
STARTED	87
COMPLETED	77
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	Intervention
Arm/Group Description	In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed. After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals. After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines.
Overall Participants	110
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	51
Sex: Female, Male (Count of Participants)
Female	110 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	110 100%

Outcome Measures

1. Primary Outcome

Title	Pathologic Complete Response (pCR)
Description	For the purpose of this study, a Pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0). Residual ductal or lobular carcinoma in situ was not considered in pCR assessments. Percentage of participants who experienced pCR is reported.
Time Frame	18 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention
Arm/Group Description	In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed. After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals. After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines.
Measure Participants	110
Number (95% Confidence Interval) [percentage of participants]	18 16.4%

2. Secondary Outcome

Title	Time to Treatment Failure (TTF)
Description	Time to Treatment Failure (TTF) is defined as the minimum of the time from first date of treatment to the either of the following dates: disease progression date (RECIST or clinical) death date treatment discontinuation
Time Frame	69 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention
Arm/Group Description	In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed. After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals. After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines. Gemcitabine: Gemcitabine Epirubicin: Epirubicin Docetaxel: Docetaxel
Measure Participants	110
Median (Full Range) [months]	13

3. Secondary Outcome

Title	Overall Survival (OS)
Description	Number of participants that are alive at 48th months
Time Frame	48 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention
Arm/Group Description	In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed. After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals. After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines.
Measure Participants	110
Count of Participants [Participants]	72 65.5%

Adverse Events

Arm/Group Title	Intervention
Arm/Group Description	In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed. After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals. After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines.
All Cause Mortality
	Intervention
	Affected / at Risk (%)	# Events
Total	38/110 (34.5%)
Serious Adverse Events
	Intervention
	Affected / at Risk (%)	# Events
Total	17/110 (15.5%)
Blood and lymphatic system disorders
Hemoglobin	1/110 (0.9%)	1
Gastrointestinal disorders
Esophagitis	1/110 (0.9%)	1
Dysphagia	1/110 (0.9%)	1
Nausea/Vomiting	1/110 (0.9%)	1
Nausea	1/110 (0.9%)	1
General disorders
Fever	1/110 (0.9%)	1
Infections and infestations
Febrile Neutropenia	11/110 (10%)	15
Infection - Other	1/110 (0.9%)	1
Infection - Pneumonia	1/110 (0.9%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnea	2/110 (1.8%)	2
Hypoxia	1/110 (0.9%)	1
Other (Not Including Serious) Adverse Events
	Intervention
	Affected / at Risk (%)	# Events
Total	71/110 (64.5%)
Blood and lymphatic system disorders
Neutrophils	45/110 (40.9%)
Platelets	19/110 (17.3%)
Hemoglobin	13/110 (11.8%)
Gastrointestinal disorders
Nausea	14/110 (12.7%)
Vomiting	10/110 (9.1%)
Diarrhea	5/110 (4.5%)
General disorders
Fatigue	10/110 (9.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.