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

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ClinicalTrials.gov Identifier: NCT01242800

Recruitment Status : Active, not recruiting

First Posted : November 17, 2010

Last Update Posted : December 14, 2017

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Eastern Cooperative Oncology Group

Study Description

Brief Summary:

RATIONALE: Early surgery may have fewer side effects and improve recovery. Palliative surgery or radiation therapy may help patients with advanced breast cancer live more comfortably. It is not yet known whether early surgery is more effective than palliative therapy for advanced breast cancer.

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Procedure: palliative surgery Procedure: therapeutic conventional surgery Radiation: palliative radiation therapy Radiation: radiation therapy	Phase 3

Detailed Description:

OBJECTIVES:

Primary

To evaluate whether early local therapy comprising surgery of intact primary disease compared to local palliative therapy only in patients with stage IV breast cancer, whose disease does not progress during initial optimal systemic therapy, will result in prolonged survival.

Secondary

To compare the time to uncontrolled chest wall disease between patients treated with these regimens.
To determine whether there is a difference in health-related quality-of-life (HRQOL) between patients treated with these regimens.
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).
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.

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	391 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients With Metastatic Breast Cancer
Actual Study Start Date :	February 8, 2011
Estimated Primary Completion Date :	June 30, 2022
Estimated Study Completion Date :	June 30, 2027

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Breast cancer

MedlinePlus related topics: Breast Cancer

Genetic and Rare Diseases Information Center resources: Breast Cancer, Male

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Procedure: palliative surgery Undergo standard palliative surgery Radiation: palliative radiation therapy Undergo standard palliative radiotherapy
Experimental: Arm II Patients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. 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.	Procedure: therapeutic conventional surgery Undergo early surgery Radiation: radiation therapy Undergo radiotherapy

Arm

Intervention/treatment

Active Comparator: 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.

Procedure: palliative surgery

Undergo standard palliative surgery

Radiation: palliative radiation therapy

Undergo standard palliative radiotherapy

Experimental: Arm II

Patients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. 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.

Procedure: therapeutic conventional surgery

Undergo early surgery

Radiation: radiation therapy

Undergo radiotherapy

Outcome Measures

Primary Outcome Measures :

Overall survival

Secondary Outcome Measures :

Uncontrolled chest wall disease
Health-related quality of life

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 120 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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 (DCIS) cancer allowed provided there has been no recurrence
Prior ipsilateral invasive cancer allowed if more than 5 years previous
No synchronous contralateral breast cancer
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

PATIENT CHARACTERISTICS:

See Disease Characteristics
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
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use an accepted and effective contraception method

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01242800

Show 411 Study Locations

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Seema A. Khan, MD	Robert H. Lurie Cancer Center

More Information


Responsible Party:	Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:	NCT01242800 History of Changes
Other Study ID Numbers:	CDR0000688097 ECOG-E2108
First Posted:	November 17, 2010 Key Record Dates
Last Update Posted:	December 14, 2017
Last Verified:	December 2017

Keywords provided by Eastern Cooperative Oncology Group:


male breast cancer stage IV breast cancer

Additional relevant MeSH terms:


Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases

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