Phase 2
N=37
Neoadjuvant Endocrine Therapy in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Node-Negative Breast Cancer
Breast Cancer · Invasive Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03219476 ↗Enrolled (actual)
37
Serious AEs
2.7%
Results posted
Oct 2022
Primary outcome: Primary: Change in Baseline of Cancer Cell Protein Levels of Human Epidermal Growth Factor Receptor (HER) Family Members (HER1-4) Following Neoadjuvant Endocrine Therapy. — 1; 17; 1; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Anastrozole (Drug); Letrozole (Drug); Exemestane (Drug); Tamoxifen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Medical College of Wisconsin
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Baseline of Cancer Cell Protein Levels of Human Epidermal Growth Factor Receptor (HER) Family Members (HER1-4) Following Neoadjuvant Endocrine Therapy. |
1; 17; 1; 1; 0; 2 | — |
| SECONDARY Number of Subjects Who Achieve Complete Radiographic Response. |
— | — |
| SECONDARY Number of Subjects Who Achieve a Partial Radiographic Response. |
1 | — |
Summary
This is an exploratory interventional study that initiates standard-of-care anti-estrogen treatment preoperatively for four weeks.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03219476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.