Trial Search Results

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

The purpose of this trial is to study early surgery to see how well it works compared to standard palliative therapy in treating patients with stage IV breast cancer. 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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Eastern Cooperative Oncology Group

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Procedure: palliative surgery
  • Procedure: therapeutic conventional surgery
  • Radiation: palliative radiation therapy
  • Radiation: radiation therapy

Phase:

Phase 3

Eligibility


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

Ages Eligible for Study

18 Years - 120 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting