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Early Surgery or Standard Pal...

Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer

Last Updated: 2023-06-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-16

Study Completion Date

2022-12-21

Brief Summary

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RATIONALE: The primary tumor might be a source of re-seeding of distant sites and therefore elimination of this source of metastasizing cells by early local therapy may be of benefit.

PURPOSE: This randomized phase III trial is studying early surgery to see how well it works compared to standard palliative therapy in treating patients with stage IV breast cancer.

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Detailed Description

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OBJECTIVES:

Primary

* To evaluate whether early local therapy of intact primary disease in patients with Stage IV breast cancer whose disease does not progress during initial optimal systemic therapy, will result in prolonged survival, compared to patients who receive local therapy for palliation only.

Secondary

* To compare the time to uncontrolled chest wall disease between patients who receive early local therapy versus patients who receive palliative local therapy.
* To determine whether there is a difference in health-related quality-of-life (HRQOL) between patients who receive early local therapy versus patients who receive palliative local therapy.
* To determine whether the absolute value of circulating tumor cells (CTC) burden at 6 months following randomization (time +6) will be lower in the palliative therapy arm than in early local therapy arm, and whether this value is inversely related to survival (lower CTC, longer survival).

Exploratory

* To collect tumor and blood specimens for future exploration of the biological interactions between the primary tumor and metastatic lesions and the effect of primary tumor resection.

OUTLINE: This is a multicenter study. Patients are stratified according to hormone receptor and treatment plan (ER+ or PR+, HER2-, endocrine therapy alone vs ER+ or PR+, and HER2-, chemotherapy and/or endocrine therapy vs ER- or PR-, and HER2- vs HER2+), and number of involved organ systems with distant disease (regional nodes in the axillary, supraclavicular, and internal mammary locations are not considered distant sites) (1 vs \> 1). Patients are randomized to 1 of 2 treatment arms in 1:1 ratio.

* Arm I: Patients receive standard palliative therapy, if needed, to address symptoms such as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other similar situations. Therapy may consist of radiotherapy alone, surgery alone, or a combination of both.
* Arm II: Patients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. Surgery is to occur no later than 10 weeks after completion of 32 weeks of systemic therapy. Free surgical margins must be achieved with re-excision or mastectomy for patients undergoing BCT. After completion of BCT, patients undergo radiotherapy once a day, 5 days per week. Patients who had mastectomy undergo radiotherapy at the discretion of treating physician.

Patients may undergo blood and tumor tissue sample collection for circulating tumor cells (CTC) burden and future studies.

Patients complete the Functional Assessment of Cancer Therapy - Breast Trial Outcome Index (FACT- TOI) and FACT - General (22) and the Breast Cancer Subscale (FACT-B) quality-of-life questionnaires at baseline and periodically during study.

After completion of study therapy, patients are followed up periodically for 5 years.

Conditions

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Breast Cancer Stage IV 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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Arm I

Patients receive standard palliative therapy, if needed, to address symptoms such as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other similar situations. Therapy may consist of radiotherapy alone, surgery alone, or a combination of both.

Group Type ACTIVE_COMPARATOR

palliative surgery

Intervention Type PROCEDURE

Undergo standard palliative surgery

palliative radiation therapy

Intervention Type RADIATION

Undergo standard palliative radiotherapy

Arm II

Patients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. Surgery is to occur no later than 10 weeks after completion of 32 weeks of systemic therapy. Free surgical margins must be achieved with re-excision or mastectomy for patients undergoing BCT. After completion of BCT, patients undergo radiotherapy once a day, 5 days per week. Patients who had mastectomy undergo radiotherapy at the discretion of treating physician.

Group Type EXPERIMENTAL

therapeutic conventional surgery

Intervention Type PROCEDURE

Undergo early surgery

radiation therapy

Intervention Type RADIATION

Undergo radiotherapy

Interventions

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palliative surgery

Undergo standard palliative surgery

Intervention Type PROCEDURE

therapeutic conventional surgery

Undergo early surgery

Intervention Type PROCEDURE

palliative radiation therapy

Undergo standard palliative radiotherapy

Intervention Type RADIATION

radiation therapy

Undergo radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of intact primary (not recurrent) invasive carcinoma of the breast

* Stage IV disease
* Confirmation of the primary tumor should be by needle biopsy (preferred)
* Incisional surgical biopsy allowed as long as there is residual palpable or tumor image in the breast
* Patients must be judged to be candidates for complete resection with free margins followed by radiation therapy (if radiation therapy is indicated)
* For women not undergoing axillary dissection, sentinel node biopsy should document an axillary nodal burden of 1-2 involved lymph nodes (i.e., ACOSOG Z-11 criteria may be applied)
* Prior non-invasive (Ductal Carcinoma In Situ) cancer allowed provided there has been no recurrence
* Prior ipsilateral invasive cancer allowed if more than 5 years previous
* Patients should have at least one organ system involved with distant metastatic disease

* If patient has only one metastatic lesion/focus, this must be proven by biopsy and the pathology report confirming the diagnosis of primary breast cancer, as well as the metastatic site, must be available
* Must have available radiologic reports documenting disease status within the past 6 weeks prior to initiating systemic therapy
* CNS metastases allowed provided projected survival \> 6 months
* Patients must have completed at least 16 weeks of optimal systemic therapy (appropriate to the tumor biological profile and the patient's age and menopausal status)

* If systemic therapy is discontinued for toxicity, but there is no distant progression and at least 12 weeks of therapy have been delivered, then the patient remains eligible
* Radiation therapy (if indicated) must begin within 12 weeks of final therapeutic surgical procedure (including re-excision for free margins and completion of axillary dissection)
* Patients may register at any time from the time of diagnosis of stage IV breast cancer (if eligibility criteria met) to the time when a maximum of 30 weeks of induction systemic therapy has been completed

* Patients must be randomized within 16-32 weeks after the start of systemic therapy
* Patients must not have experienced disease progression since the start of systemic therapy, as evidenced by radiographic documentation of disease status before treatment and within 4 weeks +/- 2 weeks prior to randomization, including:

* No new sites of disease
* No enlargement of existing sites by 20% or more in longest diameter
* No symptomatic deterioration
* Patients who require radiotherapy to bone metastases during induction systemic therapy are eligible
* Local disease at the primary site must be asymptomatic
* Hormone receptor status known
* Menopausal status not specified
* Patients must have adequate organ function to undergo local therapy 4 weeks +/- 2 weeks prior to randomization per investigator discretion and institutional guidelines
* More than 5 years since other primary cancers that were curatively treated
* Negative pregnancy test
* Fertile patients must use an accepted and effective contraception method

Exclusion Criteria

* Synchronous contralateral breast cancer
* Pregnant or nursing

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Seema A. Khan, MD

Role: PRINCIPAL_INVESTIGATOR

Robert H. Lurie Cancer Center

Locations

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University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

Site Status

Providence Cancer Center

Anchorage, Alaska, United States

Site Status

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

East Bay Radiation Oncology Center

Castro Valley, California, United States

Site Status

Enloe Cancer Center at Enloe Medical Center

Chico, California, United States

Site Status

North Bay Cancer Center

Fairfield, California, United States

Site Status

California Cancer Care, Incorporated - Greenbrae

Greenbrae, California, United States

Site Status

Todd Cancer Institute at Long Beach Memorial Medical Center

Long Beach, California, United States

Site Status

Contra Costa Regional Medical Center

Martinez, California, United States

Site Status

Community Hospital of the Monterey Peninsula Comprehensive Cancer Center

Monterey, California, United States

Site Status

El Camino Hospital Cancer Center

Mountain View, California, United States

Site Status

CCOP - Bay Area Tumor Institute

Oakland, California, United States

Site Status

St. Joseph Hospital Regional Cancer Center - Orange

Orange, California, United States

Site Status

Doctors Medical Center - San Pablo Campus

San Pablo, California, United States

Site Status

Stanford Cancer Center

Stanford, California, United States

Site Status

Boulder Community Hospital

Boulder, Colorado, United States

Site Status

Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, United States

Site Status

Presbyterian - St. Luke's Medical Center

Denver, Colorado, United States

Site Status

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, United States

Site Status

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

Site Status

Norwalk Hospital

Norwalk, Connecticut, United States

Site Status

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, United States

Site Status

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, United States

Site Status

CCOP - Christiana Care Health Services

Newark, Delaware, United States

Site Status

Herbert D. Kerman Regional Oncology Center - Daytona Beach

Daytona Beach, Florida, United States

Site Status

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status

Florida Hospital Cancer Institute at Florida Hospital Orlando

Orlando, Florida, United States

Site Status

M.D. Anderson Cancer Center at Orlando

Orlando, Florida, United States

Site Status

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, United States

Site Status

Georgia Cancer Center for Excellence at Grady Memorial Hospital

Atlanta, Georgia, United States

Site Status

Emory Crawford Long Hospital

Atlanta, Georgia, United States

Site Status

Piedmont Hospital

Atlanta, Georgia, United States

Site Status

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Site Status

Northside Hospital Cancer Center

Atlanta, Georgia, United States

Site Status

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, United States

Site Status

John B. Amos Cancer Center

Columbus, Georgia, United States

Site Status

Charles B. Eberhart Cancer Center at DeKalb Medical Center

Decatur, Georgia, United States

Site Status

Kennestone Cancer Center at Wellstar Kennestone Hospital

Marietta, Georgia, United States

Site Status

Southern Regional Medical Center

Riverdale, Georgia, United States

Site Status

Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

Savannah, Georgia, United States

Site Status

Cancer Research Center of Hawaii

Honolulu, Hawaii, United States

Site Status

Queen's Cancer Institute at Queen's Medical Center

Honolulu, Hawaii, United States

Site Status

Straub Clinic and Hospital, Incorporated

Honolulu, Hawaii, United States

Site Status

Hawaii Medical Center - East

Honolulu, Hawaii, United States

Site Status

Kuakini Medical Center

Honolulu, Hawaii, United States

Site Status

Kapiolani Medical Center at Pali Momi

‘Aiea, Hawaii, United States

Site Status

Leeward Radiation Oncology

‘Ewa Beach, Hawaii, United States

Site Status

Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

Boise, Idaho, United States

Site Status

Mountain States Tumor Institute at St. Luke's Regional Medical Center

Boise, Idaho, United States

Site Status

Saint Luke's Mountain States Tumor Institute - Fruitland

Fruitland, Idaho, United States

Site Status

Mountain States Tumor Institute - Meridian

Meridian, Idaho, United States

Site Status

Saint Luke's Mountain States Tumor Institute

Nampa, Idaho, United States

Site Status

Mountain States Tumor Institute at St. Luke's

Twin Falls, Idaho, United States

Site Status

St. Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital

Canton, Illinois, United States

Site Status