Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer; Chemotherapy as Adjuvant for LOcally Recurrent Breast Cancer

Phase 3

Completed

Conditions: Breast Cancer

Interventions: Radiation: radiation therapy
Drug: chemotherapy

Registration Number: NCT00074152

Lead Sponsor: ETOP IBCSG Partners Foundation

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether chemotherapy is effective in treating women who have undergone surgery and radiation therapy for relapsed breast cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of adjuvant chemotherapy in treating women who have undergone resection for local and/or regional relapsed breast cancer.

Detailed Description: OBJECTIVES:

Primary

* Determine the efficacy of adjuvant chemotherapy, in terms of disease-free survival, in women with radically resected loco-regional relapsed breast cancer.

Secondary

* Determine the systemic disease-free and overall survival of patients treated with this regimen.

* Determine the sites of recurrence, incidence of second (non-breast) malignancies, and causes of death without relapse of breast cancer in patients treated with this regimen.

* Determine the quality of life of patients treated with this regimen (QOL portion closed 11/13/08).

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior chemotherapy (yes vs no), estrogen receptor (ER) positive and/or progesterone receptor (PR) positive (yes vs no), and location of recurrence (breast vs mastectomy scar/chest wall vs regional lymph nodes). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive radiotherapy\* within 6 months after surgery.

* Arm II: Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients also receive radiotherapy\* within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.

NOTE: \*Patients with clear margins (R0) who received prior adjuvant radiotherapy are not required to receive further radiotherapy

Patients with ER and/or PR positive tumors also receive standard hormonal therapy.

Quality of life is assessed at baseline and at 9 and 12 months (QOL portion closed 11/13/08).

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 265 patients will be accrued for this study within 4 years.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 162

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	radiation therapy	Patients receive radiotherapy\* within 6 months after surgery.
Arm II	chemotherapy	Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.

Primary Outcome Measures

Name	Time	Method
Disease-free Survival	5 years after randomization

Secondary Outcome Measures

Name	Time	Method
Overall Survival	5 years after randomization
Sites of First Failures	5 years after randomization	Tumor recurrence in the breast, lymph nodes or other areas of the body including bone, lung, liver, central nervous system, bone marrow

Trial Locations

Locations (198): Kaiser Permanente - Deer Valley
🇺🇸
Antioch, California, United States
Kaiser Permanente - Fremont
🇺🇸
Fremont, California, United States
Kaiser Permanente Medical Center - Hayward
🇺🇸
Hayward, California, United States
Kaiser Permanente Medical Center - Oakland
🇺🇸
Oakland, California, United States
Kaiser Permanente Medical Center - Redwood City
🇺🇸
Redwood City, California, United States
Kaiser Permanente Medical Center - Richmond
🇺🇸
Richmond, California, United States
Kaiser Permanente Medical Center - Roseville
🇺🇸
Roseville, California, United States
South Sacramento Kaiser-Permanente Medical Center
🇺🇸
Sacramento, California, United States
Kaiser Permanente Medical Center - Sacramento
🇺🇸
Sacramento, California, United States
Kaiser Permanente Medical Center - San Francisco Geary Campus
🇺🇸
San Francisco, California, United States
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Kaiser Permanente - Deer Valley
🇺🇸Antioch, California, United States