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 has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001193
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: August 1999
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
Neoplasm Metastasis
Procedure: high dose melphalan and autologous bone marrow transplantation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 200
Study Start Date: November 1984
Estimated Study Completion Date: September 2000
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Patients must have a histologically documented diagnosis of mammary carcinoma and evaluable disease in the breast.

Diagnostic tissue must be reviewed at NIH.

All ICB patients must meet Haagensen's clinical criteria of ICB.

Patients with metastatic breast cancer must have evaluable disease.

There must be no history of prior cytotoxic therapy.

There must be no history of previous malignancy except for cured nonmelanoma skin cancer and cervical carcinoma in situ.

Performance status (Karnofsky scale) must be greater than 30 for patients with metastatic breast cancer.

Staging workup must be negative for distant metastases in Stage III patients.

WBC count greater than 4000 per mm(3) and platelet count greater than 100,000 per mm(3).

Normal hepatic and renal function, unless due to tumor involvement.

Patients must be willing to give informed consent and be geographically accessible for follow up.

No history of other malignant neoplasms except for curatively treated nonmelanoma skin cancer or surgically cured carcinoma of the cervix in situ.

Patients must not be poor medical or psychiatric risks because of non-malignant systemic disease which would preclude them being subjected to any of the treatments in this protocol.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001193

Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001193     History of Changes
Other Study ID Numbers: 840216, 84-C-0216
Study First Received: November 3, 1999
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Autologous
Melphalan
Stage III
Transplantation

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Melphalan
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014