Partial Breast Irradiation Using Non Invasive Approach for Early Stage Breast Cancer

• Sponsor: Jaroslaw Hepel (Other)
• Overall Status: Completed
• CT.gov ID: NCT01463007
• Collaborator: The Miriam Hospital (Other), Rhode Island Hospital (Other)
• Enrollment: 40
• Locations: 4
• Arms: 2
• Duration (Months): 116.2
• Patients Per Site: 10
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the rate of early and intermediate toxicity related to the AccuBoost System for delivery of APBI in women with resected, early stage breast cancer.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Radiation: Accelerated partial breast irradiation; Other: Extended Follow up	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: ACCELERATED PARTIAL BREAST IRRADIATION USING NON-INVASIVE IMAGE-GUIDED BREAST BRACHYTHERAPY (ACCUBOOST) FOR EARLY STAGE BREAST CANCERS: A TOXICITY ASSESSMENT
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Sep 12, 2013
• Actual Study Completion Date: Apr 6, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Radiation AccuBoost APBI- 34.0 Gy in 10fx	Radiation: Accelerated partial breast irradiation; Accuboost APBI 34.0 Gy in 10 fractions
Experimental: Extended Follow up This arm extends follow up at the Rhode Island Hospital location to 5 years. Annual mammograms and additional documentation is required to be submitted only if completed.	Other: Extended Follow up; This arm extends follow up at the Rhode Island Hospital location to 5 years. Annual mammograms and additional documentation is required to be submitted only if completed.

Outcome Measures

Primary Outcome Measures

1. Early and Intermediate Toxicity [2 years]

   Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 (Appendix 4). Acute side effects are any side effects occurring within 3 months of treatment. Intermediate side effects are any side effects occurring between 3 months and 2 years. This is reported in the outcome table.

Secondary Outcome Measures

1. Cosmetic Outcome [2 years]

   Cosmetic results will be evaluated at each follow-up visit by the treating radiation oncologist using the Harvard criteria inclusive of discomfort during treatment(Pain), Fatigue and Acute skin reaction. This is reported in the outcome table.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. A confirmed histological diagnosis of invasive breast carcinoma or DCIS

2. Age greater or equal to 50 years old

3. Life expectancy > 6 months

4. Treated by breast conserving surgery with axillary node dissection or sentinel lymph node biopsy

5. Pathologic tumor size less than or equal to 2 cm

6. Invasive ductal, mucinous, tubular or colloid histology

7. Estrogen receptor positive for invasive carcinoma.

8. Unifocal/unicentric disease

9. Negative surgical margins greater than or equal to 2 mm

10. Pathologic lymph node negative

11. No evidence of lymphovascular invasion

12. ECOG performance status of 0 or 1 (Appendix 1)

13. Informed consent signed.

Exclusion Criteria:

1. Known BRCA 1/2 Mutation; (BRCA 1 and 2 testing is not required)

2. Autoimmune disorder

3. Pregnancy

4. Breast implants

5. Psychiatric or addictive disorder that would preclude attending follow-up

6. Neoadjuvant chemotherapy (adjuvant chemotherapy is permitted)

7. Suspicious remaining microcalcification on post-surgery mammogram (unless biopsy proven benign)

8. Lobular features on histology (pure or mixed) or sarcoma histology

9. Node positive on axillary dissection or in the sentinel lymph node biopsy;

10. Extensive in situ carcinoma (EIC)

11. Multicentric or multifocal disease

12. Paget's disease of the nipple

13. Distant metastases

14. Lumpectomy cavity not well visualized on AccuBoost imaging

15. Lumpectomy cavity with 1cm margin (PTV) not adequately encompassed by any applicator (PTV > 6cm)

16. Breast separation with compression > 7cm.

17. Overlap of skin between orthogonal treatment axes.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center For Cancer Care and Research- Watson Clinic	Lakeland	Florida	United States	33805
2	Brown University Oncology Research Group	Providence	Rhode Island	United States	02903
3	Lifespan Hospitals	Providence	Rhode Island	United States	02903
4	Tacoma Radiation	Tacoma	Washington	United States	98405-4250

Sponsors and Collaborators

• Jaroslaw Hepel
• The Miriam Hospital
• Rhode Island Hospital

Investigators

• Principal Investigator: Jaroslaw Hepel, MD, Brown University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jaroslaw Hepel, principal investigator, Brown University
• ClinicalTrials.gov Identifier: NCT01463007
• Other Study ID Numbers: BrUOG 251
• First Posted: Nov 1, 2011
• Last Update Posted: May 19, 2021
• Last Verified: Apr 1, 2021

• Keywords provided by Jaroslaw Hepel, principal investigator, Brown University: invasive ductal cancer; tubular breast cancer; breast cancer; colloid; ER positive; radiation
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

Participant Flow

Pre-assignment Detail	40 patients must COMPLETE treatment. 41 were registered because 1 was removed secondary to Physician decision to not continue treatment.

Arm/Group Title	Radiation
Arm/Group Description	AccuBoost APBI- 34.0 Gy in 10fx Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions
Period Title: Overall Study
STARTED	41
COMPLETED	40
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Radiation
Arm/Group Description	AccuBoost APBI- 34.0 Gy in 10fx Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions
Overall Participants	41
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	16 39%
>=65 years	25 61%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	61.46
Sex: Female, Male (Count of Participants)
Female	41 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	41 100%

Outcome Measures

1. Primary Outcome

Title	Early and Intermediate Toxicity
Description	Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 (Appendix 4). Acute side effects are any side effects occurring within 3 months of treatment. Intermediate side effects are any side effects occurring between 3 months and 2 years. This is reported in the outcome table.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Radiation	Extended to 5 Years of Follow Up-Rhode Island Hospital Only
Arm/Group Description	AccuBoost APBI- 34.0 Gy in 10fx Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions	Follow up has been extended to include follow up visits at 2,6 weeks and at 4,6,12,18,24 months then annually (+/- 6 months) for an additional 3 years for a total of approximately 5 years of follow up.
Measure Participants	41	28
Number [participants]	40 97.6%	28 NaN

2. Secondary Outcome

Title	Cosmetic Outcome
Description	Cosmetic results will be evaluated at each follow-up visit by the treating radiation oncologist using the Harvard criteria inclusive of discomfort during treatment(Pain), Fatigue and Acute skin reaction. This is reported in the outcome table.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Radiation
Arm/Group Description	AccuBoost APBI- 34.0 Gy in 10fx Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions
Measure Participants	41
Number [participants]	35 85.4%

Adverse Events

Time Frame	Data was collected from signing of ICF until 2 years post treatment.
Arm/Group Title	Radiation
Arm/Group Description	AccuBoost APBI- 34.0 Gy in 10fx Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions
All Cause Mortality
	Radiation
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Radiation
	Affected / at Risk (%)	# Events
Total	1/41 (2.4%)
Investigations
Infection	1/41 (2.4%)	1
Creatinine	1/41 (2.4%)	1
Hypokalemia	1/41 (2.4%)	1
Bicarbonate	1/41 (2.4%)	1
SGOT	1/41 (2.4%)	1
Alkaline Phosphatase value	1/41 (2.4%)	1
Hyperbilirubineamia	1/41 (2.4%)	1
Hypoalbuminemia	1/41 (2.4%)	1
Leukocytes	1/41 (2.4%)	1
Hemoglobin	1/41 (2.4%)	1
Neutrophils	1/41 (2.4%)	1
INR	1/41 (2.4%)	1
PTT	1/41 (2.4%)	1
Fibrinogen	1/41 (2.4%)	1
Other (Not Including Serious) Adverse Events
	Radiation
	Affected / at Risk (%)	# Events
Total	40/41 (97.6%)
Investigations
Discomfort	35/41 (85.4%)	35
acute skin rxn	32/41 (78%)	32
skin induration/fibrosis	11/41 (26.8%)	11
hyperpigmentation	22/41 (53.7%)	22
fatigue	18/41 (43.9%)	18
breast volume	11/41 (26.8%)	11
seroma	2/41 (4.9%)	2
fat necrosis	2/41 (4.9%)	2
Itching	0/41 (0%)	0
Fibrosis Cosmesis	1/41 (2.4%)	1
Talangiectasis	8/41 (19.5%)	8
breast pain	7/41 (17.1%)	7
Nausea	1/41 (2.4%)	1
Diarrhea	1/41 (2.4%)	1
erythema	1/41 (2.4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.