Know Cancer

forgot password

Phase I/II Partial Breast Irradiation With Concurrent Chemotherapy

Phase 1/Phase 2
39 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

Phase I/II Partial Breast Irradiation With Concurrent Chemotherapy


- Assess the potential acute and late skin and subcutaneous toxicities in women with
resected stage I or II breast cancer treated with partial breast irradiation (PBI) and
concurrent cyclophosphamide/doxorubicin (AC) chemotherapy.

- Assess the cosmetic effects of partial breast irradiation/chemotherapy (PBIC) in these

- Assess the local control rate in patients treated with this regimen.

OUTLINE: Patients undergo partial breast radiotherapy once daily, 5 days a week, for 3
weeks. Patients also receive doxorubicin IV over 15 minutes and cyclophosphamide IV over 30
minutes on day 1. Treatment with doxorubicin and cyclophosphamide repeats every 2 weeks for
up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for approximately 10

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed adenocarcinoma of the breast by routine hematoxylin and
eosin (H&E) staining

- Primary tumor ≤ 4 cm and 0-3 positive axillary lymph nodes (pathologic T1-2,
pathologic N0-N1, M0)

- Patients with lymph nodes positive only by cytokeratin staining (i.e., H&E
negative) are eligible

- No squamous cell carcinoma or sarcoma of the breast

- Patients must have undergone a segmental mastectomy (SM) with a level I and ll
axillary dissection or sentinel lymph node biopsy within the past 14 weeks

- Surgical margins at the time of SM must be negative (> 3 mm) for both invasive
carcinoma and for non-invasive ductal carcinoma

- No active local-regional disease

- Hormone receptor status not specified


- ECOG performance status 0-1

- Sex: female

- Menopausal status not specified

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective non-hormonal contraception

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

- No other serious or poorly controlled medical or psychiatric condition that could be
exacerbated by, or complicate compliance with study treatment


- No prior radiation therapy to the breast

- No prior trastuzumab (Herceptin ®)

- No other concurrent chemotherapy

- No concurrent hormonal therapy except the following:

- Steroids given for adrenal failure

- Hormones administered for non-disease-related conditions (e.g., insulin for
diabetes, synthroid for hypothyroidism)

- Intermittent dexamethasone as an antiemetic or premedication

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Potential acute, late skin, and subcutaneous toxicity

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Richard C. Zellars, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Federal Government

Study ID:

J0381 CDR0000446085



Start Date:

July 2004

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • Breast Neoplasms



Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410