Clinical trial · Interventional
High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Women With Metastatic or Recurrent Breast Cancer
A Randomized Trial of High-Dose Chemotherapy and Autologous Stem Cell Therapy Versus Standard Therapy in Women With Metastatic Breast Cancer Who Have Responded to Anthracycline or Taxane-Based Induction Chemotherapy
- 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known whether standard therapy is more effective than high dose chemotherapy for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of high dose chemotherapy plus peripheral stem cell transplantation with that of standard therapy in treating women with metastatic or recurrent breast cancer that has responded to previous chemotherapy.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| mitoxantrone hydrochloride | Drug | Mitoxantrone | ALIAS |
| tamoxifen citrate | Drug | Tamoxifen | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 16 Years
- Maximum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed breast cancer Metastatic disease and/or axillary node or chest wall recurrence following mastectomy diagnosed at least 3 months since prior adjuvant chemotherapy Radiologic scans required No inflammatory carcinoma of the breast without metastases (i.e. T4d M0) No previously untreated inflammatory carcinoma of the breast (T4d) No recurrent breast cancer diagnosed less than 3 months since prior adjuvant chemotherapy No history or evidence of CNS (brain or leptomeningeal) metastases Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 16 to 60 Sex: Female Performance status: ECOG 0-2 Menopausal status: Not specified Life expectancy: Not specified Hematopoietic: Hemoglobin at least 100 g/L Granulocyte count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: AST and/or ALT no greater than 3 times upper limit of normal OR AST and/or ALT no greater than 5 times upper limit of normal, if liver metastases Bilirubin no greater than 1.5 times upper limit of normal Renal: Serum creatinine no greater than 2 times upper limit of normal Cardiovascular: No history of congestive heart failure OR At least 1 year since prior myocardial infarction LVEF at least 45% or normal (ECHO or MUGA are acceptable) Other: No prior or concurrent malignancies allowed, except adequately treated squamous or basal cell carcinoma of the skin or in situ carcinoma of the cervix, or cancer treated more than 5 years ago and presumed cured Not HIV positive No clinical evidence of AIDS Not pregnant or nursing Effective contraception required of fertile patients No major medical illness precluding safe administration of planned treatment or required follow-up PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic response modifier therapy Chemotherapy: No prior chemotherapy for metastatic or recurrent breast cancer Induction chemotherapy required Endocrine therapy: Prior hormonal therapy allowed No concurrent hormonal therapy Radiotherapy: Concurrent radiotherapy allowed for pain control or to solitary bone or soft tissue sites Surgery: Prior oophorectomy allowed See Disease Characteristics
References
Publications (2)
- RESULTCrump M, Gluck S, Tu D, Stewart D, Levine M, Kirkbride P, Dancey J, O'Reilly S, Shore T, Couban S, Girouard C, Marlin S, Shepherd L, Pritchard KI. Randomized trial of high-dose chemotherapy with autologous peripheral-blood stem-cell support compared with standard-dose chemotherapy in women with metastatic breast cancer: NCIC MA.16. J Clin Oncol. 2008 Jan 1;26(1):37-43. doi: 10.1200/JCO.2007.11.8851. Epub 2007 Nov 19. PMID 18025439
- RESULTDancey J, Crump M, Gluck S, et al.: Quality of life (QOL) analysis of a randomized trial of high-dose chemotherapy (HDCT) with peripheral stem cell transplant (PSCT) versus standard chemotherapy (SCT) in women with metastatic breast cancer (MBC): National Cancer Institute of Canada Clinical Trials Group study (NCIC CTG) MA-16 . [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-3010, 749, 2003.