S9927 Radiation Therapy After Surgery, Chemotherapy, and/or Hormone Therapy in Stage II Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-06-30

Study Completion Date

2005-03-31

Brief Summary

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RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether mastectomy, chemotherapy, and/or hormone therapy are more effective with or without radiation therapy in treating breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of mastectomy, chemotherapy, and/or hormone therapy with or without radiation therapy in treating women who have stage II breast cancer.

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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surgery

surgery followed by observation

Group Type ACTIVE_COMPARATOR

surgery

Intervention Type PROCEDURE

surgery

surgery followed by RT

Surgery followed by radiation therapy

Group Type EXPERIMENTAL

radiation therapy

Intervention Type RADIATION

surgery

Intervention Type PROCEDURE

surgery

Interventions

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radiation therapy

Intervention Type RADIATION

surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lori J. Pierce, MD

Role: STUDY_CHAIR

University of Michigan Rogel Cancer Center

Michael G. Haddock, MD

Role: STUDY_CHAIR

Mayo Clinic

Stephen B. Edge, MD

Role: STUDY_CHAIR

Roswell Park Cancer Institute

Eric A. Strom, MD, FACR

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Lawrence J. Solin, MD, FACR

Role: STUDY_CHAIR

Abramson Cancer Center at Penn Medicine

Lawrence B. Marks, MD

Role: STUDY_CHAIR

Duke University

Timothy J. Whelan, MD

Role: STUDY_CHAIR

Margaret and Charles Juravinski Cancer Centre

Melvin Deutsch, MD

Role: STUDY_CHAIR

UPMC Cancer Center at UPMC Presbyterian

Locations

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Cancer Care Ontario-Hamilton Regional Cancer Centre

Hamilton, Ontario, Canada

Site Status

Countries

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Canada