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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01242800
Recruitment Status : Active, not recruiting
First Posted : November 17, 2010
Last Update Posted : December 22, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

Study Description
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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 Not Applicable

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
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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
Actual Primary Completion Date : April 30, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: Assessed at baseline, then every 3 months within 2 years and every 6 months between 2-5 years, up to 5 years ]
    Overall survival, defined as time from randomization to death from any cause. All patients will be followed for survival through 5 years. Cases with incomplete follow-up or without record of vital status will be censored at the date of last contact.


Secondary Outcome Measures :
  1. Uncontrolled chest wall disease [ Time Frame: Assessed at baseline, then every 3 months within 2 years and every 6 months between 2-5 years, up to 5 years ]
    The chest wall/breast will be called "controlled" if there is no clinical or radiological evidence of the local tumor; or if there is evidence of the primary tumor but no skin nodules, ulceration, or chest wall fixation. Time to uncontrolled chest wall disease is defined as time from randomization to the development of uncontrolled chest wall disease. Patients with controlled chest wall will be censored at the last date of evaluation.

  2. Health-related quality of life [ Time Frame: Assessed at baseline, randomization, 6, 18 and 30 months after randomization ]
    The FACT-Breast Trial Outcome Index will be used as the primary HRQL endpoint. FACT-B TOI scores at baseline, randomization, 6, 18 and 30 months after randomization will be calculated and compared for participants randomized to early local therapy versus palliative local therapy. The change of FACT-B TOI scores over time will be compared between treatment arms as well. For the palliative local therapy arm, the change of QOL from randomization to the time of decision for local therapy will also be measured.


Eligibility Criteria
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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
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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


Locations
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Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Seema A. Khan, MD Robert H. Lurie Cancer Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT01242800    
Other Study ID Numbers: CDR0000688097
ECOG-E2108
First Posted: November 17, 2010    Key Record Dates
Last Update Posted: December 22, 2021
Last Verified: May 2021
Keywords provided by Eastern Cooperative Oncology Group:
male breast cancer
stage IV breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases