Aggressive Local Therapy for Limited Bone-Only Metastasis to Improve Progression-Free Survival in Breast Cancer Patients

NCT00929214 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2008-0319NCI-2011-02165
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to find out if adding local therapy (surgery and/or radiation) to standard therapy (chemotherapy or endocrine therapy) in the treatment of patients with metastatic breast cancer can help to control the disease for a longer period of time than standard therapy alone.

Conditions

Breast Cancer

Keywords

Breast Cancer; Metastasized; Limited bone-only metastasis; Local Therapy; Radiation; Radiation Therapy; RT; Surgery; Standard Therapy; Chemotherapy; Endocrine Therapy

Outcome Measures

Primary Outcomes (1)

• Number of Patients with Progression-Free Survival (PFS)

  Progression-free survival defined as 1) development of distant soft tissue or visceral metastasis at any time, 2) progression of bone lesion(s) that received planned local therapy (as defined by the imaging response criteria described by Hamaoka et al., and 3) development of new bone lesions after patient receives planned local therapy. Development of additional bone metastasis prior to receiving planned local therapy not be considered as event if the total number of bone metastasis is 3 or less. An event has occurred if additional bone metastasis develops and total number of bone metastasis is 4 or more.

  Study assessment at 9 Months

Study Arms (1)

Standard Therapy + Local Therapy

EXPERIMENTAL

Systemic Standard Therapy (chemotherapy and/or endocrine therapy) + Local Therapy (surgery and/or radiation)

Drug: Standard Therapy; Procedure: Local Therapy

Interventions

Local Therapy PROCEDURE

Surgery and/or Radiation Therapy With no more than 3 bone metastases, local treatments including high-dose radiation therapy and/or surgery will be given. Radiation therapy involves daily treatments during weekdays that may last 5 to 7 weeks in a row. Each daily treatment may last 30 - 40 minutes. Surgery, including recovery, may last 4 to 6 weeks.

Also known as: Radiation Therapy, RT, XRT, Surgery

Standard Therapy + Local Therapy

Standard Therapy DRUG

Chemotherapy and/or Endocrine Therapy: For 3 - 9 months, all patients will receive systemic chemotherapy agents appropriate for the tumor characteristics and patient's prior treatment history, and may also be placed on endocrine therapy as determined by the treating medical oncologist.

Also known as: Chemotherapy, Endocrine Therapy, Systemic Chemotherapy

Standard Therapy + Local Therapy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer with metastasis to skeletal sites only
• to 3 bone metastatic sites (metastatic lesions in the same bone that are within 3 cm of each other are considered as one site)
• KPS greater than or equals to 70
• Absolute neutrophil count of \> 1500 per microliter and platelet count \> 100,000 per microliter; AST and alkaline phosphatase \< = 2.5 X normal limits, bilirubin \< = 1.5 x normal limits, calculated creatinine clearance \> 50 ml/min using Cockcroft-Gault formula: CrCl male = (140-age) x (wt. in kg)/(Serum Cr x 72); CrCl female = 0.85 x (CrCl male)
• Patients may or may not have started bis-phosphonates.
• Patients who have received prior chemotherapy for their original breast cancer treatment are still eligible.
• Previous use of systemic therapy for bone metastasis is allowable as long as the systemic therapy use fits within the treatment plan as described in Proposed Treatment/Study Plan. (If the patient received less than 3 - 9 months of systemic therapy previously, the use of additional systemic therapy may be necessary to fit within the treatment plan)
• Treating physician assesses tumor to be sufficiently distant from sensitive structures to be able to achieve greater than or equal to 66 Gy. (i.e., spinal cord tolerance respected in vertebral body metastasis.
• Patients with immanent risk of fracture(s) may receive local therapy prior to systemic therapy. Otherwise systemic therapy should be given first as outlined in abstract treatment study plan sections 1 and 2.

You may not qualify if:

• Distant metastasis to organs (local recurrence and regional lymph node recurrence are not considered as distant metastasis) other than bone
• Prior radiation to site(s) of distant metastasis of bone
• History of scleroderma and systemic lupus erythematosus which increases the risk of toxicity from radiation treatment
• Second primary malignancy (skin cancer other than melanoma allowed) that is disease free for less than 3 years
• Premenopausal and postmenopausal (amenorrheic for less than 12 months) women with either a positive or no pregnancy test (serum or urine) at baseline within 7 days study enrollment. Postmenopausal women who are amenorrheic for more than 12 months do not require pregnancy test.
• Women with child-bearing potential not using a reliable an appropriate contraceptive method.
• Patients with child-bearing potential will agree to use contraception while on study and for 30 days from the date of the last therapy on protocol.
• If the patient requires surgery of the bone metastasis, clinically serious comorbidities that render patient not medically fit for surgery (e.g. congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmias and chronic lung disease not well controlled with medication; myocardial infarction within 12 months of enrollment)
• Central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant to preclude informed consent or interfere with complying with protocol treatments.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Standard of Care; Drug Therapy; Neoadjuvant Therapy; Hyperthermia, Induced; Radiotherapy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Therapeutics; Combined Modality Therapy

Study Officials

• Eric A. Strom, MD, BS

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2009
• First Posted: June 26, 2009
• Study Start: June 24, 2009
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-11

Locations

US (1)