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Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer
Not Recruiting
Trial ID: NCT01242800
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
Stanford Investigator(s)
Frederick M. Dirbas, MD
Associate Professor of Surgery (General Surgery)
Eligibility
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
Intervention(s):
radiation: palliative radiation therapy
radiation: radiation therapy
procedure: palliative surgery
procedure: therapeutic conventional surgery
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061