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A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients With Metastatic Breast Cancer

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Trial Conditions
  • Breast Cancer
What is the purpose of this trial?

RATIONALE: 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. 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.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

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

Gender: Both
Steward Physician(s)
  • Seema A. Khan, MD
Facilities
  • St. Elizabeth's Medical Center - Recruiting
Trial Interventions
Procedure
  • palliative surgery
  • therapeutic conventional surgery
Radiation
  • palliative radiation therapy
  • radiation therapy
For more information about this trial, contact

Dorcas Chi

Phone: 617-789-3000

Dorcas Chi

Phone: (617) 789-3000


Physician Researcher

Investigator Name:

  • Seema A. Khan, MD

Other Information

Sponsor: Eastern Cooperative Oncology Group
Phase: Phase 3
Trial ID: NCT01242800
Volunteers:  Not Accepting Healthy Volunteers

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