Eliminating Surgery or Radiotherapy After Systemic Therapy in Treating Patients With HER2 Positive or Triple Negative Breast Cancer
Estrogen Receptor Negative, HER2 Positive Breast Carcinoma, HER2/Neu Negative
About this trial
This is an interventional treatment trial for Estrogen Receptor Negative
Eligibility Criteria
Inclusion Criteria:
- (Cohort A) 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
- (Cohort A) 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
- (Cohort A) Patient desires breast conserving therapy
- (Cohort A) 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
- (Cohort A) Female sex
- (Cohort A) 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
- (Cohort A) 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
- (Cohort B) ER and/or PR positive, HER2 negative
- (Cohort B) Clinical stage T1N0M0, unicentric non-lobular breast cancer, no lymphovascular space invasion,
- (Cohort B) At least 40 years of age.
- (Cohort B) Oncotype ≤ 25 if age ≥ 50 years
- (Cohort B) Oncotype 0-20 and tumor size ≤ 1.5cm if age 40-49 years.
- (Cohort B) Patient agrees to take anti-estrogen therapy and is interested in breast conservation
- (Cohort B) Female sex.
- (Cohort B) 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.
- (Cohort B) No history of prior radiation to the area of the breast that would require protocol-mandated treatment
- (Cohort C) Pathologically confirmed invasive breast cancer defined as radiologic clinical stage T1 or T2 (≤ 5 cm), N0, clinical stage M0.
- (Cohort C) HER2 positive (IHC 3+ and or FISH amplified) receiving any standard routine clinical NST regimen.
- (Cohort C) Patient desires breast conserving therapy.
- (Cohort C) Age 30 years or older.
- (Cohort C) Female sex.
- (Cohort C) 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.
- (Cohort C) Patient must have an initial nodal ultrasound that does not demonstrate suspicious lymph nodes; any suspicious lymph nodes should be biopsied to determine if nodal metastatic disease present.
- (Cohort C) Patient must have no evidence of residual invasive tumor or DCIS on pathologic review of the lumpectomy surgical specimen
- (Cohort C) Patient must have no evidence of metastatic disease involving the lymph nodes on pathologic review of the lymph node surgical specimen.
- (Cohort C) Unifocal disease or limited multifocal disease that can be excised in a single lumpectomy specimen
Exclusion Criteria:
- Radiologic evidence for a stage T3 or clinical stage T4 breast cancer in Cohort A/C; radiologic evidence for a stage T2-T3 or clinical stage T4 breast cancer in Cohort B.
- 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 in Cohort A/B.
Sites / Locations
- Banner Health/Banner Research
- Baptist MD Anderson Cancer Center
- Queen's Medical CenterRecruiting
- Mayo ClinicRecruiting
- MD Anderson Cancer Center at Cooper-Voorhees
- Carolinas Medical Center/Levine Cancer InstituteRecruiting
- University of Pittsburgh Cancer Institute (UPCI)Recruiting
- M D Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Cohort A
Cohort B
Cohort C
Neoadjuvant chemotherapy therapy Biopsy: if no disease remaining - stay on the study and receive radiation (skip breast surgery) H&P and Imaging every 6 months Treatment (whole breast irradiation, EBRT) Within 12 weeks of completing neoadjuvant systemic therapy, patients undergo whole breast irradiation over 15-25 fractions on consecutive days. Patients then undergo EBRT boost over 7 fractions on consecutive days beginning the day following completion of whole breast irradiation.
Neoadjuvant endocrine therapy for 6 months Radiation if there is less than 25% tumor increase Biopsy: if negative - additional endocrine therapy under the guidance of medical oncologist (skip breast surgery) H&P and Imaging every 6 months Cohort B Radiation: Treatment (Stereotactic ablative radiotherapy -SABR) Following 3-6 months of endocrine therapy, if less than 25% tumor increase, patients undergo SABR irradiation over 10 fractions every other business day.
Optional biopsy for nanomechanical biomarker assessment Neoadjuvant chemotherapy therapy Surgery (& optional biopsy nanomechanical biomarker assessment): if no disease remaining - stay on the study and skip radiation H&P and Imaging every 6 months