Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer - Full Text View

Sponsors and Collaborators:	International Breast Cancer Study Group National Surgical Adjuvant Breast and Bowel Project (NSABP)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00074152

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: chemotherapy Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Randomized Clinical Trial Of Adjuvant Chemotherapy For Radically Resected Loco-Regional Relapse Of Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Radiation Therapy Surgery

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Disease-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Designated as safety issue: No ]
Systemic disease-free survival [ Designated as safety issue: No ]
Quality of life as assessed by linear analog self assessment at baseline and 9 and 12 months (QOL portion closed 11/13/08) [ Designated as safety issue: No ]
Sites of first recurrence [ Designated as safety issue: No ]
Secondary (non-breast) malignancies [ Designated as safety issue: No ]
Causes of death without relapse of breast cancer [ Designated as safety issue: No ]

Estimated Enrollment:	265
Study Start Date:	July 2002
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Active Comparator Patients receive radiotherapy* within 6 months after surgery.	Radiation: radiation therapy Given within 6 months after surgery
Arm II: Experimental 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.	Drug: chemotherapy Given within 10 weeks after surgery.

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

See Disease Characteristics

Endocrine therapy

Not specified

Radiotherapy

See Disease Characteristics

Surgery

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00074152

Show 251 Study Locations

Sponsors and Collaborators

International Breast Cancer Study Group

National Surgical Adjuvant Breast and Bowel Project (NSABP)

Investigators

Investigator:	Stefan Aebi, MD	University Hospital Inselspital, Berne
Investigator:	Irene L. Wapnir, MD	Stanford University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Wapnir IL, Aebi S, Gelber S, Anderson SJ, Láng I, Robidoux A, Mamounas EP, Wolmark N. 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. 2008 Sep 11; [Epub ahead of print]

Wapnir IL, Aebi S, Geyer CE, Zahrieh D, Gelber RD, Anderson SJ, Robidoux A, Bernhard J, Maibach R, Castiglione-Gertsch M, Coates AS, Piccart MJ, Clemons MJ, Costantino JP, Wolmark N; IBCSG; BIG; NSABP. 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. 2008 Jun;8(3):287-92.

Responsible Party:	International Breast Cancer Study Group ( Clinical Trials Office )
Study ID Numbers:	CDR0000343619, IBCSG-27-02, BIG-1-02, EU-20320, NSABP-B-37, EUDRACT-2005-001484-64
Study First Received:	December 10, 2003
Last Updated:	June 27, 2009
ClinicalTrials.gov Identifier:	NCT00074152 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

recurrent breast cancer
stage I breast cancer
stage II breast cancer

stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Study placed in the following topic categories:

Skin Diseases
Adjuvants, Immunologic
Breast Neoplasms
Breast Diseases
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on July 02, 2009