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OncoMatch/Clinical Trials/NCT05472792

Compare Adjuvant Monotherapy With Endocrine or Accelerated Partial Breast Irradiation After Lumpectomy

Is NCT05472792 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifene for breast cancer.

Phase 2RecruitingUNC Lineberger Comprehensive Cancer CenterNCT05472792Data as of May 2026

Treatment: tamoxifen, anastrozole, exemestane, letrozole, fulvestrant, toremifeneThe aim of this prospective study is to investigate quality of life and oncologic outcomes in low-risk elderly breast cancer patients randomized to adjuvant therapy with accelerated partial breast irradiation (APBI) alone or endocrine therapy alone after lumpectomy. The study population will include women age 65 years and older with low-risk tumor characteristics (tumor size \<2cm, grade 1-2, node-negative). APBI will consist of 5 fractions of radiation therapy delivered every other day to the lumpectomy cavity. Endocrine therapy will be chosen by the treating medical oncologist with an aim of 5 years duration, as tolerated by the patient. Quality of life outcomes will be measured at 1 year following lumpectomy and compared between groups. We hypothesize that the use of APBI may be superior in terms of quality of life when compared to endocrine therapy alone following lumpectomy while providing equivalent rates of disease control and overall survival. In this phase II study, we anticipate enrolling 90 women at N.C. Cancer Hospital in Chapel Hill, NC.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: ESR1 overexpression (≥10% ER by IHC) (≥10% by IHC)

Estrogen receptor (ER)/ Progesterone receptor (PR) positive (greater than or equal to 10% ER and PR by immunohistochemistry [IHC] staining)

Required: PR (PGR) overexpression (≥10% PR by IHC) (≥10% by IHC)

Estrogen receptor (ER)/ Progesterone receptor (PR) positive (greater than or equal to 10% ER and PR by immunohistochemistry [IHC] staining)

Required: HER2 (ERBB2) negative (0 or 1+ by IHC or negative by ISH) (0 or 1+ by IHC or negative by ISH)

Human epidermal growth factor receptor 2 (HER2) - according to American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) guidelines (0 or 1+ following IHC staining or proven negative by in-situ hybridization [ISH])

Disease stage

Required: Stage PT1 (pathological)

Grade: 12 (overall tumor grade)

Pathological T1 (pT1) stage; Grade 1 or 2 overall tumor grade

Prior therapy

Must have received: breast conserving surgery

Subjects with completed breast conserving surgery (BCS) with or without sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND).

Cannot have received: systemic chemotherapy

Exception: pre- or post-operative systemic chemotherapy while on this study

Pre- or post-operative systemic chemotherapy while on this study.

Cannot have received: breast or thoracic radiation

Prior breast or thoracic radiation.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of North Carolina · Chapel Hill, North Carolina

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