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

• Status: Active, not recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical College of Wisconsin
• Treatments: Anastrozole; Aromatase Inhibitors; Estrogens; Exemestane; Hormones; Letrozole; Tamoxifen

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.