Clinical trial · Interventional
Neoadjuvant Endocrine Therapy in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Node-Negative Breast Cancer
Neoadjuvant Endocrine Therapy in Hormone Receptor-Positive HER2-Negative Node-Negative Breast Cancer Patients to Assess Responses and Mechanisms of Endocrine Resistance
NCT03219476CI-TRIAL-00089059completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an exploratory interventional study that initiates standard-of-care anti-estrogen treatment preoperatively for four weeks.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Invasive Breast Cancer | Invasive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anastrozole | Drug | Anastrozole | ALIAS |
| Exemestane | Drug | Exemestane | ALIAS |
| Letrozole | Drug | Letrozole | ALIAS |
| Tamoxifen | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant endocrine therapy treatment (physician's choice)
- description
- Once enrolled, patients would be treated with the current standard-of-care endocrine therapy. Choice of endocrine therapy (aromatase inhibitors or tamoxifen) would be decided by medical oncologist, following a review of the patient's medical history and menstrual status. The patient would be treated with endocrine therapy in a neoadjuvant setting for four weeks, with dosing continuing until surgery.
- interventionNames
- Drug: Anastrozole
- Drug: Letrozole
- Drug: Exemestane
- Drug: Tamoxifen
Primary outcomes (1)
- measure
- Change in Baseline of Cancer Cell Protein Levels of Human Epidermal Growth Factor Receptor (HER) Family Members (HER1-4) Following Neoadjuvant Endocrine Therapy.
- timeFrame
- At four weeks.
- description
- ImmunoHistoChemistry (IHC) will be used. The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. If the score is 0 to 1+ (up to 25% of cells stained), it's called "HER2 negative." If the score is 2+ (approximately 50% of cells stained), it's called "borderline." A score of 3+ (approximately 75% or more of cells stained) is called "HER2 positive." Upregulation means increased staining from a prior observation; Downregulation means decreased staining from a prior observation; and No Change means similar staining from a prior observation.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDChaudhary LN, Jorns JM, Sun Y, Cheng YC, Kamaraju S, Burfeind J, Gonyo MB, Kong AL, Patten C, Yen T, Cortina CS, Carson E, Johnson N, Bergom C, Tsaih SW, Banerjee A, Wang Y, Chervoneva I, Weil E, Chitambar CR, Rui H. Frequent upregulation of HER2 protein in hormone-receptor-positive HER2-negative breast cancer after short-term neoadjuvant endocrine therapy. Breast Cancer Res Treat. 2023 Oct;201(3):387-396. doi: 10.1007/s10549-023-07038-3. Epub 2023 Jul 17. PMID 37460683