Neoadjuvant Endocrine Therapy in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Node-Negative Breast Cancer

Completed · Phase 2

Conditions studied: Breast Cancer, Invasive Breast Cancer

In brief

This is an exploratory interventional study that initiates standard-of-care anti-estrogen treatment preoperatively for four weeks.

Key facts

Study ID

NCT03219476

Run by

Medical College of Wisconsin

People needed

37

Starts

2017-02-05

Expected to finish

2025-03-20

Last updated by the study team

2025-04-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female; age ≥18 years.
• Pathologically proven diagnosis of invasive breast cancer, clinically stage I-II.
• Clinically lymph node negative, confirmed by clinical exam and/or ultrasound imaging.
• Estrogen- and/or progesterone-receptor-positive tumor, defined ≥1% positively staining cells by immunohistochemistry, according to the current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
• HER2/neu must be negative by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH).
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Pretreatment evaluations (minimum diagnostic workup) within 28 days prior to study
• Qualify for anti-endocrine treatment (per medical oncologist).
• Informed consent provided.
• If history of contralateral breast cancer, patient completed all treatment two years prior
• No treatment for this breast cancer or any malignancy within two years (except non-melanomatous skin cancer, carcinoma in situ of the cervix and contralateral breast cancer)
• Using adequate methods of contraception; negative pregnancy test.
• No strong CYP2D6 inhibitors.
• Adequate organ function with baseline lab values.
• Absolute neutrophil count (ANC) ≥ 1500/µL.
• Hemoglobin (Hb) ≥ 9g/dL.
• Platelet count ≥ 100,000/µL.
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3x upper limit of normal (ULN).
• Serum bilirubin within ≤ 1.5 x ULN.

You may not qualify if…

• American Joint Committee on Cancer (AJCC) clinical T4, N1-3 or M1, breast cancer.
• Synchronous non-breast malignancy (exceptions include non-melanomatous skin cancer, carcinoma in situ of the cervix).
• Purely noninvasive breast cancer (i.e., ductal carcinoma in situ, lobular carcinoma in situ).
• Men with breast cancer.
• Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent.
• Pregnant or lactating women.

Where it is running

• Froedtert Hospital — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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