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NCT00001193 · ClinicalTrials.gov registry record · Phase 2
A Multimodality Treatment Approach to Patients With Inflammatory Cancer of the Breast and Locally Advanced Non-Inflammatory Stage III Breast Cancer and Stage IV Breast Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
NCT00001193: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00001193 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 200 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001193, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
Study Summary
This study is designed to evaluate the efficacy of high dose melphalan and autologous bone marrow transplantation given as consolidation therapy to patients with inflammatory or metastatic carcinoma of the breast in complete remission. All patients entered will receive induction therapy with cyclophosphamide, adriamycin, methotrexate and 5-fluorouracil with hormonal synchronization utilizing tamoxifen and premarin as in a previous Medicine Branch protocol (MB-160C). Among patients with inflammatory carcinoma of the breast, pathologic complete responders will receive irradiation to the breast and regional lymph nodes; convertible partial responders and clinical complete responders with residual disease on biopsy will undergo surgical resection of bulk disease followed by irradiation of the chest wall and regional lymph nodes excluding the axilla. Both groups of responders will be randomized to receive either systemic consolidation therapy with high dose melphalan (180 mg/M2 total dose over 3 days) and autologous bone marrow transplantation followed by maintenance therapy or maintenance therapy alone. Complete responders in this noninflammatory group will not receive further therapy since, historically, they have done well following induction and local therapy, with maintenance therapy alone. Patients with metastatic breast cancer will be assessed for response throughout induction therapy. Complete and convertable partial responders will receive consolidative therapy and be randomized to ABMT followed by 6 months of maintenance therapy vs. maintenance alone.
Interventions
- PROCEDURE high dose melphalan and autologous bone marrow transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 1984-11 |
| Est. Completion | 2000-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001193
The ClinicalTrials.gov registry entry for NCT00001193 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which high dose melphalan and autologous bone marrow transplantation is the first listed.
NCT00001193 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001193 about?
NCT00001193 is a clinical study titled "A Multimodality Treatment Approach to Patients With Inflammatory Cancer of the Breast and Locally Advanced Non-Inflammatory Stage III Breast Cancer and Stage IV Breast Cancer". This study is designed to evaluate the efficacy of high dose melphalan and autologous bone marrow transplantation given as consolidation therapy to patients with inflammatory or metastatic carcinoma of the breast in complete remission. All patients entered will receive induction therapy with cycloph...
What is the current status of trial NCT00001193?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 1984-11. Estimated completion is 2000-09.
What interventions are being tested in trial NCT00001193?
The interventions under investigation include: high dose melphalan and autologous bone marrow transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT00001193?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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