Multicenter Trial for Eliminating Breast Cancer Surgery or Radiotherapy in Exceptional Responders to Neoadjuvant Systemic Therapy

  • STATUS
    Recruiting
  • End date
    Jan 31, 2026
  • participants needed
    120
  • sponsor
    M.D. Anderson Cancer Center
Updated on 18 October 2022
cancer
metastatic disease
estrogen
breast cancer
progesterone
metastasis
immunohistochemistry
HER2
biomarker analysis
triple negative breast cancer
progesterone receptor
estrogen receptor
invasive breast cancer

Summary

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.

Description

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 (cohort A).

II. To determine the pCR rate 6 months after radiation therapy based on image- guided biopsy (cohort B).

III. To determine the 6 months, 1, 2, 3, and 5-year ipsilateral breast tumor recurrence rate among patients who undergo surgery alone without radiation (cohort C).

SECONDARY OBJECTIVES:

I. To determine the 6 months, 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 (cohort C).

II. 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.

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

IV. 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.

V. 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.

VI. 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).

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

VIII. 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.

IX. To explore if radiation genomic sensitivity scores and Oncotype performed on the initial diagnostic core biopsy specimen correlate with pCR rates in Cohort B.

X. To determine if changes in blood-based RNA Sequencing are elicited with radiation in Cohort B, measured at baseline, at the first 4-6 week follow-up after radiation, and at the 6 month post-radiation follow-up.

XI. In Cohort B to determine the 3 year rate of tumor control/progression free survival (PFS).

XII. In Cohort C to determine whether nanomechanical biomarkers or quantification of stromal and tumor TILS can predict for low risk of local recurrence in exceptional responders who omit radiation therapy.

OUTLINE

For Cohorts A and B, 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.

Details
Condition Estrogen Receptor Negative, HER2 Positive Breast Carcinoma, HER2/Neu Negative, Invasive Breast Carcinoma, Progesterone Receptor Negative, Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7, Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Triple-Negative Breast Carcinoma
Treatment radiation therapy, laboratory biomarker analysis, questionnaire administration, quality-of-life assessment, Questionnaire, breast biopsy, whole breast irradiation, external beam radiation therapy
Clinical Study IdentifierNCT02945579
SponsorM.D. Anderson Cancer Center
Last Modified on18 October 2022

Eligibility

Yes No Not Sure

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

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
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
Patient is participating in a NST protocol in which surgical excision of the breast and or lymph nodes are required in Cohort A/B
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