Trial record 1 of 1 for:    NCT01242800
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Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer

This study is currently recruiting participants.
Verified December 2012 by Eastern Cooperative Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT01242800
First received: November 16, 2010
Last updated: February 7, 2014
Last verified: December 2012
  Purpose

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 Intervention Phase
Breast Cancer
Procedure: palliative surgery
Procedure: therapeutic conventional surgery
Radiation: palliative radiation therapy
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: 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

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Uncontrolled chest wall disease [ Designated as safety issue: No ]
  • Health-related quality of life [ Designated as safety issue: No ]

Estimated Enrollment: 880
Study Start Date: February 2011
Estimated Primary Completion Date: June 2025 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01242800

  Show 411 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Principal Investigator: Seema A. Khan, MD Robert H. Lurie Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT01242800     History of Changes
Other Study ID Numbers: CDR0000688097, ECOG-E2108
Study First Received: November 16, 2010
Last Updated: February 7, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 21, 2014