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Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women With One to Three Positive Axillary Nodes Phase III


Phase 3
21 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women With One to Three Positive Axillary Nodes Phase III


OBJECTIVES:

- Compare overall and disease-free survival in women with stage II breast cancer with one
to three positive nodes treated with radiotherapy vs observation only after mastectomy
and adjuvant chemotherapy and/or hormonal therapy.

- Compare local regional control in patients treated with these regimens.

- Assess the potential toxic effects of radiotherapy in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior
systemic hormonal therapy (chemotherapy with or without hormonal therapy vs hormonal therapy
alone), prior taxane exposure (yes vs no), and duration of chemotherapy (no chemotherapy vs
less than 3 months vs 3-5 months vs 6 months or more). Patients are randomized to one of two
treatment arms.

- Arm I: Patients undergo radiotherapy 5 days a week for 5 weeks.

- Arm II: Patients are observed for disease progression. Patients are followed every 6
months for 2 years and then annually for 15 years.

PROJECTED ACCRUAL: A total of 2,500 patients (1,250 per treatment arm) will be accrued for
this study within 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage II adenocarcinoma of the breast (T1-2, N1, M0)

- Primary tumor no greater than 5 cm

- At least 1 but no more than 3 positive axillary lymph nodes

- Nodes cannot be positive solely by cytokeratin staining

- No apocrine, adenocystic, or squamous cell carcinomas or sarcomas of the breast

- No bilateral breast cancer

- No active local regional disease

- Must have undergone a modified radical mastectomy with a level I and II with or
without a level III axillary dissection (at least 10 nodes examined) within the past
8 months

- Surgical margins negative for invasive and noninvasive ductal carcinoma

- No gross extracapsular disease or residual disease in the axilla

- Microscopic extracapsular extension allowed

- No mastectomy after local failure following lumpectomy

- Must have received adjuvant chemotherapy and/or hormonal therapy after mastectomy

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age:

- 21 and over

Sex:

- Female

Menopausal status:

- Pre- or post-menopausal

Performance status:

- Zubrod 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No other prior malignancy within the past 5 years except adequately treated basal
cell or squamous cell skin cancer or carcinoma in situ of the cervix

- No serious medical or psychiatric illness that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior trastuzumab (Herceptin)

Chemotherapy:

- See Disease Characteristics

- No more than 6 weeks since prior adjuvant chemotherapy

- No other prior chemotherapy

- Concurrent adjuvant chemotherapy allowed

Endocrine therapy:

- See Disease Characteristics

- Concurrent adjuvant hormonal therapy allowed

Radiotherapy:

- No prior chest wall or nodal radiotherapy

Surgery:

- See Disease Characteristics

- Breast reconstruction allowed

Other:

- Concurrent registration on another adjuvant chemotherapy or hormonal therapy study is
allowed

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Lori J. Pierce, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067971

NCT ID:

NCT00005983

Start Date:

June 2000

Completion Date:

March 2005

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • Breast Neoplasms

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