Breast Cancer
Conditions
Keywords
stage I breast cancer, stage II breast cancer
Brief summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cyclophosphamide and doxorubicin after surgery may kill any tumor cells that remain. PURPOSE: This phase I/II trial is studying the side effects of radiation therapy when given together with cyclophosphamide and doxorubicin and to see how well they work in treating women with stage I or stage II breast cancer who have undergone surgery.
Detailed description
OBJECTIVES: * 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 patients. * 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 years. PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
Interventions
DRUGcyclophosphamide
chemotherapy
DRUGDoxorubicin
doxorubicin
RADIATIONradiation
radiation
Sponsors
National Cancer Institute (NCI)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: * 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 PRIOR CONCURRENT THERAPY: * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Acute, Late Skin, and Subcutaneous Toxicity | up to 5 years | Number of participants with Grade 4 toxicity as defined by the following criteria: Acute Skin Toxicity: 0=No change, 1= Follicular, faint, or dull erythema/epilation/dry/desquamation/decreased swelling, 2= Tender or bright erythemal patchy moist desquamation/moderate edema, 3= Confluent moist desquamation other than skin folds, piting edema, 4= Ulceration, hemorrahage, necrosis, Late Skin Toxicity: 0= None, 1= Slight Atrophy, Pigmentation change, some hair loss, 2= Patch atrophy, moderate telangectasias, total hair loss, 3= Marked atrophy, gross telangectasias, 4= Ulceration; Subcutaneous Tissue Toxicity: 0= None, 1= Slight induration (fibrosis) and loss of subcutaneous fat, 2= Moderate fibrosis but asymptomatic; slight field contracture; \<10% linear reduction, 3= Severe induration and loss subcutaneous tissue; field contracture \>10% linear reduction; 4= Necrosis |
Countries
United States
Participant flow
Pre-assignment details
Two patients did not initiate study procedures: one was found to have residual gross disease during treatment planning, and another withdrew consent.
Participants by arm
| Arm | Count |
|---|---|
| Experimental cyclophosphamide: chemotherapy
doxorubicin hydrochloride: chemotherapy
adjuvant therapy: chemotherapy
radiation therapy: chemotherapy | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | social circumstances | 1 |
Baseline characteristics
| Characteristic | Experimental |
|---|---|
| Age, Customized Age <= 45 years | 5 Participants |
| Age, Customized Age >= 45 years | 20 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 21 / 25 |
| serious Total, serious adverse events | 1 / 25 |
Outcome results
Primary
Number of Participants Experiencing Acute, Late Skin, and Subcutaneous Toxicity
Number of participants with Grade 4 toxicity as defined by the following criteria: Acute Skin Toxicity: 0=No change, 1= Follicular, faint, or dull erythema/epilation/dry/desquamation/decreased swelling, 2= Tender or bright erythemal patchy moist desquamation/moderate edema, 3= Confluent moist desquamation other than skin folds, piting edema, 4= Ulceration, hemorrahage, necrosis, Late Skin Toxicity: 0= None, 1= Slight Atrophy, Pigmentation change, some hair loss, 2= Patch atrophy, moderate telangectasias, total hair loss, 3= Marked atrophy, gross telangectasias, 4= Ulceration; Subcutaneous Tissue Toxicity: 0= None, 1= Slight induration (fibrosis) and loss of subcutaneous fat, 2= Moderate fibrosis but asymptomatic; slight field contracture; \<10% linear reduction, 3= Severe induration and loss subcutaneous tissue; field contracture \>10% linear reduction; 4= Necrosis
Time frame: up to 5 years
Population: Data was only collected on participants who completed the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental | Number of Participants Experiencing Acute, Late Skin, and Subcutaneous Toxicity | 0 Participants |