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Eliminating Surgery after Systemic Therapy in Treating Patients with HER2 Positive or Triple Negative Breast Cancer

Trial Status: Active

This clinical trial studies eliminating surgery and how well radiation therapy after systemic therapy works in treating patients with HER2 positive or triple negative breast cancer when image-guided biopsy shows no residual cancer. Patients then receive standard breast radiotherapy.

Inclusion Criteria

  • Pathologically confirmed unicentric invasive breast cancer defined as radiologic clinical stage T1 or T2 (=< 5 cm), N0 or N1 (=< 4 abnormal axillary nodes on initial ultrasound), clinical stage M0
  • HER2 positive (immunohistochemistry [IHC] 3+ and or fluorescence in situ hybridization [FISH] amplified) or triple receptor negative (triple negative [TN], estrogen receptor [ER]/progesterone receptor [PR] < 10% HER2 negative [IHC 1+ or 2+ FISH non-amplified]) receiving any standard routine clinical NST regimen
  • Patient desires breast conserving therapy
  • Age 40 years or older; this age cutoff is justified because breast cancers in women under the age of 40 are known to have a significantly higher risk of IBTR presumably due to underlying biologic differences
  • Female sex
  • If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer
  • Patient must have an initial nodal ultrasound that does not demonstrate more than four suspicious lymph nodes, any suspicious lymph nodes should be biopsied to determine if nodal metastatic disease present

Exclusion Criteria

  • Radiologic evidence for a stage T3 or clinical stage T4 breast cancer
  • Clinical or pathologic evidence for distant metastases
  • Prior diagnosis of invasive or ductal carcinoma in situ breast cancer in the ipsilateral breast
  • Clinical evidence of progression of disease > 20% in the breast or new evidence of nodal metastases
  • Patient is known to be pregnant
  • Patient is participating in a NST protocol in which surgical excision of the breast and or lymph nodes are required

Arizona

Phoenix
Banner Health / Banner Research
Status: APPROVED
Contact: Stephanie C. Byrum
Phone: 480-256-6444

Florida

Jacksonville
Baptist MD Anderson Cancer Center
Status: APPROVED
Contact: Beth Ann Lesnikoski

Hawaii

Honolulu
Queen's Medical Center
Status: ACTIVE
Contact: Clayton Dai Kwock Chong
Phone: 808-691-8777

Minnesota

Rochester
Mayo Clinic in Rochester
Status: ACTIVE
Contact: Judy C. Szemere Boughey
Phone: 507-284-2511

New Jersey

Voorhees
MD Anderson Cancer Center at Cooper-Voorhees
Status: ACTIVE
Contact: Catherine Elizabeth Loveland-Jones
Phone: 856-135-6207

North Carolina

Charlotte
Carolinas Medical Center / Levine Cancer Institute
Status: ACTIVE
Contact: Richard L. White
Phone: 980-442-6358

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE
Contact: Emilia J. Diego
Phone: 412-641-3083

Texas

Conroe
MD Anderson in The Woodlands
Status: ACTIVE
Contact: Henry Mark Kuerer
Houston
M D Anderson Cancer Center
Status: ACTIVE
Contact: Henry Mark Kuerer
Phone: 713-745-5043
League City
MD Anderson League City
Status: ACTIVE
Contact: Henry Mark Kuerer
Phone: 713-745-5043
Sugar Land
MD Anderson in Sugar Land
Status: ACTIVE
Contact: Henry Mark Kuerer
Phone: 713-745-5043

PRIMARY OBJECTIVES:

I. To determine the 6 months (mo), 1, 2, 3, and 5-year biopsy confirmed ipsilateral breast tumor recurrence rate (IBTR, invasive, and/or in situ) among patients who do not undergo surgery.

SECONDARY OBJECTIVES:

I. To determine the number (%) of patients where final biopsy reveals residual disease and quantify the residual disease (residual cancer burden, RCB) determined by routine pathologic examination of surgery specimens.

II. To assess baseline, 6 months, 1, 3, and 5 years decisional comfort of clinical trial participation using the Decisional Regret Scale (DRS).

III. To determine patient-reported cosmetic outcome, breast pain, and functional status using the Breast Cancer Treatment Outcomes Scale (BCTOS) at baseline, 6 months, 1, 3, and 5 years.

IV. To determine the 6 mo, 1, 2, 3, and 5-year incidence of ipsilateral breast and nodal recommendation and performance of biopsy based on breast imaging follow-up.

V. Correlate "liquid biopsy" analyses (after neoadjuvant systemic therapy [NST], 6 months and one year postradiotherapy or surgery) among protocol participants with pathologic complete response (pCR), utilizing circulating tumor cells (CTCs) and circulating tumor-deoxyribonucleic acid (DNA) (ctDNA).

VI. Among patients who decide to proceed with routine surgery, record the results of final biopsy compared with routine pathologic examination of surgery specimens.

VII. To determine patient-reported quality of life using the Functional Assessment of Cancer Therapy-Breast version 4 (FACT B+4) instrument at baseline, 6 months, 1, 3, and 5 years after treatment.

OUTLINE:

Within 12 weeks of completing neoadjuvant systemic therapy, patients undergo whole breast irradiation over 15-25 fractions on consecutive days. Patients then undergo external beam radiation therapy (EBRT) boost over 7 fractions on consecutive days beginning the day following completion of whole breast irradiation.

After completion of study treatment, patients are followed up every 6 months for 5 years.

Trial Phase Phase NA

Trial Type Treatment

Lead Organization
M D Anderson Cancer Center

Principal Investigator
Henry Mark Kuerer

  • Primary ID 2016-0046
  • Secondary IDs NCI-2016-01929
  • Clinicaltrials.gov ID NCT02945579