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

Not Recruiting

Trial ID: NCT01242800


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
Frederick M. Dirbas, MD

Associate Professor of Surgery (General Surgery)


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

   - 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

      - 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

      - 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

   - 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


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

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