NCT01242800
Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer
NA
COMPLETED
NCT01242800
INTERVENTIONAL
A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients With Metastatic Breast Cancer
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.
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
Breast Cancer
Stage IV Breast Cancer
- TREATMENT
-
- Type: PROCEDURE
- Name: palliative surgery
- Description: Undergo standard palliative surgery
- Arm Group Labels: Arm I
-
- Type: PROCEDURE
- Name: therapeutic conventional surgery
- Description: Undergo early surgery
- Arm Group Labels: Arm II
-
- Type: RADIATION
- Name: palliative radiation therapy
- Description: Undergo standard palliative radiotherapy
- Arm Group Labels: Arm I
-
- Type: RADIATION
- Name: radiation therapy
- Description: Undergo radiotherapy
- Arm Group Labels: Arm II
- Eastern Cooperative Oncology Group