Clinical trial · Interventional
Combination Chemotherapy With or Without Colony-stimulating Factors in Treating Women With Breast Cancer
A Phase III Adjuvant Trial Of Sequenced EC + Filgrastim + Epoetin Alfa Followed By Paclitaxel Versus Sequenced AC Followed By Paclitaxel Versus CEF As Therapy For Premenopausal Women And Early Postmenopausal Women Who Have Had Potentially Curative Surgery For Node Positive Or High Risk Node Negative Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: 1. . To compare the effects on breast cancer of three different combinations of drugs which are commonly used to treat this disease. 2. . It is not yet known which treatment regimen is most effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy given with or without epoetin alfa in treating women who have undergone surgery for stage I, stage II, or stage III breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| epirubicin hydrochloride | Drug | Epirubicin | ALIAS |
| epoetin alfa | Biological | — | UNRESOLVED |
| filgrastim | Biological | Filgrastim | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1: CEF
- description
- 6 cycles - q 28 days (6 months) - Cyclophosphamide 75 mg/m2 - po - Days 1-14 - Epirubicin 60 mg/m2 - IV - Days 1 and 8 - 5 Fluorouracil: 500mg/m2 - IV - Days 1 and 8 + Continuous Antibiotic Prophylaxis with Cotrimoxazole 960 mg (i.e.2x480 mg tablets) po-bid or Ciprofloxacin 500 mg - po-bid
- interventionNames
- Drug: cyclophosphamide
- Drug: epirubicin hydrochloride
- Drug: fluorouracil
- type
- ACTIVE_COMPARATOR
- label
- Arm 2: EC/T
- description
- 6 cycles - q 14 days (3 months) - Epirubicin 120 mg/m2 - IV - Day 1 - Cyclophosphamide 830 mg/m2 - IV - Day 1 - Filgrastim 5μg/kg/d - SC - Days 2 - 13 + Epoetin Alfa 40,000 IU - SC - once weekly (to begin within 1 week after start of protocol therapy as needed) 21 days from last administration of EC (EC/T) 4 cycles - q 21 days (3 months) - Adriamycin 60 mg/m2 - IV - Day 1 - Cyclophosphamide 600 mg/m2 - IV - Day 1 - 21 days from last administration of AC 4 cycles - q 21 days (3 months) - Paclitaxel 175 mg/m2 IV 3 hour infusion
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the breast that is potentially curable
* T0-4 (dermal involvement on pathology assessment only), N0-2, M0
* No clinical T4 disease
* Previously treated with one of the following:
* Total mastectomy and level II axillary node dissection
* Partial mastectomy and level II axillary node dissection with planned breast radiotherapy after completion of adjuvant chemotherapy regimen\*
* Patients with a positive sentinel node biopsy must undergo level II axillary node dissection or sufficient nodal sampling
* If microscopic residual in situ or invasive disease is present at total or partial mastectomy margins, planned radiotherapy must also include a boost to the tumor bed
* No residual tumor in the axilla after dissection
* Axillary node positive
* Negative nodes allowed if the tumor is ≥ 1 cm and 1 or more of the following criteria defining high-risk node-negative disease are met:
* Histological grade III or,
* Estrogen receptor negative or,
* Lymphatic/vascular invasion
* Hormone receptor status:
* Estrogen receptor status known
PATIENT CHARACTERISTICS:
Age:
* 60 and under
Sex:
* Female
Menopausal status:
* Pre- or postmenopausal
Performance status:
* ECOG 0-2
Life expectancy:
* At least 5 years
Hematopoietic:
* WBC ≥ 3,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic:
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
Renal:
* Creatinine ≤ 1.5 times ULN
Cardiovascular:
* LVEF ≥ limit of normal by MUGA or echocardiogram
* No arrhythmia requiring ongoing treatment
* No congestive heart failure
* No documented coronary artery disease
Other:
* No other malignancy except:
* Adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* Ductal or lobular carcinoma in situ that has been curatively treated by surgery alone
* Other prior malignancies (except breast cancer) curatively treated more than 5 years prior to study entry
* No serious underlying medical illness or psychiatric or addictive disorder that would preclude study compliance
* No known hypersensitivity to E. coli-derived products, mammalian-cell derived products, or any study agents
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective non-hormonal contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior immunotherapy for breast cancer
* No concurrent pegfilgrastim or darbepoetin alfa (Arm II)
* Allowed on arms 1 and 3 if medically necessary
Chemotherapy:
* No prior chemotherapy for breast cancer
Endocrine therapy:
* No prior hormonal therapy for breast cancer
* No concurrent hormone replacement therapy
* No concurrent selective estrogen-receptor modulators (e.g., raloxifene for the treatment or prevention of osteoporosis)
* No concurrent oral contraceptives (i.e., birth control pills)
* No other concurrent aromatase inhibitors
Radiotherapy:
* See Disease Characteristics
* No prior radiotherapy for breast cancer
Surgery:
* See Disease Characteristics
* No more than 12 weeks since prior total or partial mastectomy (including re-excision of margins)
Other:
* At least 30 days since prior investigational drugs
* No other concurrent investigational drugs
* Concurrent bisphosphonates for the treatment or prevention of osteoporosis allowedReferences
Publications (3)
- RESULTBurnell MJ, O'Connor EM, Chapman JW, et al.: Triple-negative receptor status and prognosis in the NCIC CTG MA.21 adjuvant breast cancer trial. [Abstract] J Clin Oncol 26 (Suppl 15): A-550, 2008.
- RESULTBurnell MJ, Levine MN, Chapman JA, et al.: A phase III adjuvant trial of sequenced EC + filgrastim + epoetin-alpha followed by paclitaxel compared to sequenced AC followed by paclitaxel compared to CEF in women with node-positive or high-risk node-negative breast cancer (NCIC CTG MA.21). [Abstract] J Clin Oncol 25 (Suppl 18): A-550, 2007.
- RESULTBurnell M, Levine M, Chapman JA, et al.: A randomized trial of CEF versus dose dense EC followed by paclitaxel versus AC followed by paclitaxel in women with node positive or high risk node negative breast cancer, NCIC CTG MA.21: results of an interim analysis. [Abstract] 29th Annual San Antonio Breast Cancer Symposium, December 14-17, 2006, San Antonio, Texas. A-53, 2006.