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

Trial ID or NCT#

NCT01242800

Status

not recruiting iconNOT RECRUITING

Purpose

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.

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

Eligibility Criteria

Ages Eligible for Study: 18 to 120
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * Diagnosis of intact primary (not recurrent) invasive carcinoma of the breast
  2. * 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
  3. * 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)
  4. * 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
  5. * 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:
  6. * 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:
  1. * Synchronous contralateral breast cancer* Pregnant or nursing
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Investigator(s)

Frederick M Dirbas
Frederick M Dirbas
Breast specialist, Breast surgeon, Surgical oncologist
Associate Professor of Surgery (General Surgery) and, by courtesy, of Radiation Oncology (Radiation Therapy)

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Contact

CCTO
650-498-7061

View on ClinicalTrials.gov