Clinical trial · Interventional
Comparison of Biological Therapies Following Combination Chemotherapy and Bone Marrow or Peripheral Stem Cell Transplantation in Women With Stage II or Stage III Breast Cancer
High-Dose Chemotherapy Followed By Autologous Hematopoietic Stem Cell Support And One Of Two Regimens Aimed At Modifying Immune Reconstitution In Women With High Risk Stage 2 And Stage 3 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: 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 or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Biological therapy may interfere with the growth of the cancer cells. It is not yet known which post-transplant biological therapy regimen is more effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of cyclosporine and interferon gamma to that of interleukin-2 following combination chemotherapy and bone marrow or peripheral stem cell transplantation in women who have 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 (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| autologous bone marrow transplantation | Procedure | — | UNRESOLVED |
| carboplatin | Drug | Carboplatin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cyclosporine | Drug | — | UNRESOLVED |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| recombinant interferon gamma | Biological | — | UNRESOLVED |
| thiotepa | Drug | Thiotepa | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * Stage II with at least 10 lymph nodes involved with malignancy OR * Stage III (any T3b-T4, N2 or N3, M0) * Ineligible for other high priority national or institutional study * No metastasis to brain (confirmed by CT or MRI) * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 to physiologic 65 Sex: * Female Menopausal status: * Not specified Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin less than 2 times normal Renal: * Creatinine less than 1.5 times normal Cardiovascular: * LVEF at least 45% Other: * HIV negative * Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 3 cycles of prior chemotherapy required * Stage II patients must have completed 4-6 courses of doxorubicin and/or taxol-based adjuvant chemotherapy * Stage III patients must have achieved complete or partial response to 4-6 courses of doxorubicin and/or taxol-based induction chemotherapy * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified
References
Publications (1)
- RESULTVahdat LT, Cohen DJ, Zipin D, Lo KS, Donovan D, Savage D, Tiersten A, Nichols G, Troxel A, Hesdorffer CS. Randomized trial of low-dose interleukin-2 vs cyclosporine A and interferon-gamma after high-dose chemotherapy with peripheral blood progenitor support in women with high-risk primary breast cancer. Bone Marrow Transplant. 2007 Aug;40(3):267-72. doi: 10.1038/sj.bmt.1705692. Epub 2007 Jun 11. PMID 17563739