Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	Any age	Other	IBCSG-27-02 BIG-1-02, EU-20320, NCT00074152, NSABP-B-37, EUDRACT-2005-001484-64

Special Category: CTSU trial

Objectives

Primary

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

Secondary

1. Determine the systemic disease-free and overall survival of patients treated with this regimen.
2. 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.
3. Determine the quality of life of patients treated with this regimen (QOL portion closed 11/13/08).

Entry Criteria

Disease Characteristics:

• Histologically confirmed invasive breast cancer
  • First local and/or regional (i.e., ipsilateral axillary or internal mammary lymph node region) recurrence after primary treatment with mastectomy or lumpectomy/quadrantectomy with clear surgical margins
    • Local failure is defined as a tumor recurrence in any soft tissue of the ipsilateral conserved breast or the chest wall, mastectomy scar, and/or skin
    • Regional failure is defined as a tumor recurrence in the ipsilateral axillary lymph nodes, extranodal soft tissue of the ipsilateral axilla, and/or ipsilateral internal mammary. Regional failure does not include supraclavicular lymph nodes or tumor in the opposite breast
  • No other prior recurrence in any site, including local
• Surgical resection of the recurrence meeting 1 of the following criteria:
  • Uninvolved ("clear") margins and planned radiotherapy with at least 40 Gy for patients who had no prior adjuvant radiotherapy
  • Mastectomy of the recurrence with uninvolved ("clear") margins after lumpectomy/quadrantectomy alone for the primary
• Adjuvant trastuzumab (Herceptin®) therapy or other HER-2 directed therapies are allowed for patients with HER-2 positive tumors and must be declared prior to randomization
• No evidence of distant metastasis, including ipsilateral supraclavicular lymph nodes, by x-ray or CT scan of the chest, ultrasound or CT scan of the abdomen and pelvis, or bone scintigraphy only if alkaline phosphatase is > 2 times normal or if medically indicated (e.g., bone pain)
• No macroscopically incomplete surgery
• No bilateral malignancy except carcinoma in situ
• No suspicious mass in the opposite breast unless that mass has been proven by biopsy to be benign
• No skeletal pain of unknown cause
  • No hot spots on bone scan for which metastases cannot be ruled out by x-ray, MRI, and/or CT scan
• Hormone receptor status:
  • Determined in the recurrent tumor by immunohistochemistry and/or ligand-binding assay
  • Estrogen receptor positive or negative
  • Progesterone receptor positive or negative

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

Surgery

• See Disease Characteristics

Patient Characteristics:

Age

• Any age

Sex

• Female

Menopausal status

• Not specified

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• No elevated alkaline phosphatase

Renal

• Not specified

Other

• Fertile patients must use effective non-hormonal contraception
• Medically suitable for chemotherapy of 3-6 months duration
• No other primary malignant tumors except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer
• No non-malignant systemic disease that would preclude study treatment or prolong follow-up
• No psychiatric or addictive disorder that would preclude giving informed consent
• No history of noncompliance to medical regimens or potential for being unreliable

Expected Enrollment

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

Outcomes

Disease-free survival

Overall survival
Systemic disease-free survival
Quality of life as assessed by linear analog self assessment at baseline and 9 and 12 months (QOL portion closed 11/13/08)
Sites of first recurrence
Secondary (non-breast) malignancies
Causes of death without relapse of breast cancer

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.

Wapnir IL, Aebi S, Gelber S, et al.: Progress on BIG 1-02/IBCSG 27-02/NSABP B-37, a prospective randomized trial evaluating chemotherapy after local therapy for isolated locoregional recurrences of breast cancer. Ann Surg Oncol 15 (11): 3227-31, 2008.[PUBMED Abstract]

Wapnir IL, Aebi S, Geyer CE, et al.: A randomized clinical trial of adjuvant chemotherapy for radically resected locoregional relapse of breast cancer: IBCSG 27-02, BIG 1-02, and NSABP B-37. Clin Breast Cancer 8 (3): 287-92, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

International Breast Cancer Study Group

Stefan Aebi, MD, Study coordinator		Ph: 41-31-632-4114 Email: stefan.aebi@insel.ch

National Surgical Adjuvant Breast and Bowel Project

Irene Wapnir, MD, Study coordinator		Ph: 650-736-1353 Email: wapnir@stanford.edu

Registry Information
Official Title		A Randomized Clinical Trial Of Adjuvant Chemotherapy For Radically Resected Loco-Regional Relapse Of Breast Cancer
Trial Start Date		2002-07-02
Trial Completion Date		2011-06-01 (estimated)
Registered in ClinicalTrials.gov		NCT00074152
Date Submitted to PDQ		2003-10-21
Information Last Verified		2010-01-30
NCI Grant/Contract Number		CA12027

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