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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


Phase 2
N/A
N/A
Not Enrolling
Both
Breast Neoplasms, Neoplasm Metastasis

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Trial Information

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 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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

840216

NCT ID:

NCT00001193

Start Date:

November 1984

Completion Date:

September 2000

Related Keywords:

  • Breast Neoplasms
  • Neoplasm Metastasis
  • Autologous
  • Melphalan
  • Stage III
  • Transplantation
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Metastasis

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892