Phase 3
N=5,351
Combination Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA (cT1-3, N0-1, M0) Breast Cancer and Positive Axillary Lymph Nodes
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00003782 ↗Enrolled (actual)
5,351
Serious AEs
3.0%
Results posted
Oct 2012
Primary outcome: Primary: Overall Survival — 83; 79; 79 percentage of patients alive
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- cyclophosphamide (Drug); docetaxel (Drug); doxorubicin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- NSABP Foundation Inc
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
83; 79; 79 | — |
| PRIMARY Disease Free Survival |
— | — |
| SECONDARY Toxicities Among the 3 Regimens |
— | — |
| SECONDARY Quality of Life Among Breast Cancer Patients |
— | — |
| SECONDARY Amenorrhea in Premenopausal Women |
— | — |
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy after surgery may kill any tumor cells remaining following surgery. It is not yet known which regimen of combination chemotherapy is more effective in treating breast cancer with positive axillary lymph nodes.
PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy in treating women who have undergone surgery for stage I, stage II, or stage IIIA breast cancer with positive axillary lymph nodes.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed invasive adenocarcinoma of the breast
- Confined to the breast and ipsilateral axilla on clinical exam
- Stage I, II, or IIIA (cT1-3, N0-1, M0)
- At least one axillary lymph node with evidence of tumor on histologic exam
- Sentinel node biopsy allowed if followed by axillary dissection
- No suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes, unless proven on biopsy to not be involved with tumor
- No bilateral malignancy or mass in the opposite breast, unless mass is histologically proven to be benign
- Must have undergone either a prior total mastectomy and axillary dissection (modified radical mastectomy) OR
- Prior lumpectomy and axillary dissection
- Patients must receive radiotherapy after randomization (not before) AND after chemotherapy
- Margins must be clear
- No ipsilateral lymph nodes that are fixed to one another or to other structures (N2 disease) and/or any positive nonaxillary lymph nodes (intramammary nodes are considered axillary nodes)
- No histologically evident invasive tumor or ductal carcinoma in situ
- No diffuse tumors by mammography that would not be surgically amenable to lumpectomy
- No other dominant mass in the ipsilateral breast remnant unless one of the following is true:
- Histologically benign
- Surgically removed with clear margins if malignant
- No ulceration, erythema, infiltration of the skin or underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude
- Tethering or dimpling of the skin or nipple inversion allowed
- No metastatic disease
- Skeletal pain allowed if bone scan negative for metastases
- Hormone receptor status:
- Estrogen and progesterone status determined
PATIENT CHARACTERISTICS:
Age:
- greater than or equal to 18 years
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Not specified
Life expectancy:
- At least 10 years, excluding diagnosis of cancer
Hematopoietic:
- Absolute neutrophil count at least 1, 500/mm^3 (may be less, if in the opinion of the investigator, this represents an ethnic or racial variation)
- Platelet count at least 100, 000/mm^3* NOTE: *If platelet count is above the upper limit of normal (ULN), significant underlying hematologic disorders must be excluded
Hepatic:
- Bilirubin no greater than ULN
- Alkaline phosphatase less than 2.5 times ULN*
- SGOT less than 1.5 times ULN*
- No nonmalignant systemic hepatic disease that would preclude study participation NOTE: *Alkaline phosphatase and SGOT cannot both be greater than ULN
Renal:
- Creatinine no greater than normal
- No nonmalignant systemic renal disease that would preclude study participation
Cardiovascular:
- No nonmalignant systemic cardiovascular disease that would preclude study participation
- LVEF at least lower limit of normal (LLN) by MUGA or echocardiogram
- No active cardiac disease that would preclude use of doxorubicin or docetaxel, including the following:
- Any prior myocardial infarction
- Angina pectoris requiring anti-anginal medication
- History of congestive heart failure
- Cardiac arrhythmia requiring medication
- Severe conduction abnormality
- Valvular disease with documented cardiac function compromise
- Cardiomegaly on chest x-ray or ventricular hypertrophy on EKG, unless LVEF at least LLN
- Poorly controlled hypertension (diastolic greater than 100 mm/Hg)
- Hypertension well controlled by medication allowed
Other:
- No grade 2 or greater peripheral neuropathy
- No other prior malignancy within the past 5 years except:
- Effectively treated squamous cell or basal cell skin cancer
- Surgically treated carcinoma in situ of the cervix
- Segmentally resected lobular carcinoma in situ of the ipsilateral or contralateral breast
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
- No nonmalignant systemic disease that would preclude study p
Data sourced from ClinicalTrials.gov (NCT00003782). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.