Clinical trial · Interventional
NEOADjuvant Aromatase Inhibitor and Pertuzumab/Trastuzumab for Women With Breast Cancer
A Phase II Study of NEOADjuvant Aromatase Inhibitor and Pertuzumab/Trastuzumab (NEOADAPT)
NCT02689921CI-TRIAL-00035069NEOADAPTunknownPhase 2ClinicalTrials.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 a prospective, single-arm, phase II study of 32 evaluable patients treated with NEOADjuvant Aromatase inhibitor and Pertuzumab/Trastuzumab (NEOADAPT) without chemotherapy for hormone receptor positive (HR+), \[i.e. Estrogen Receptor positive (ER+) and/or Progesterone Receptor positive (PR+)\] HER2+ localized, non-metastatic stage I - IIb breast cancer.
Conditions
Conditions (1)
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anastrozole | Drug | Anastrozole | ALIAS |
| Exemestane | Drug | Exemestane | ALIAS |
| Letrozole | Drug | Letrozole | ALIAS |
| Leuprolide Acetate | Drug | Leuprolide | ALIAS |
| Pertuzumab | Drug | Pertuzumab | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant Biological Therapy
- description
- Subjects will receive an aromatase inhibitor for the duration of the study \[exemestane (tablet, oral, 25 mg/day), letrozole (tablet, oral, 2.5 mg/day) or anastrozole (tablet, oral, 1 mg/day)\]. Premenopausal subjects will receive leuprolide acetate (11.25 mg, intramuscular injection, 3-month intervals). Pertuzumab will be given by intravenous infusion in 3-week cycles until disease progression (Cycle 1 Day 0: 840 mg, infused over 60-90 minutes; subsequent cycles: 420 mg, infused over 30-60 minutes). Trastuzumab will be given by intravenous infusion in 3-week cycles until disease progression (Cycle 1 Day 0: 8 mg/kg, infused over 60-90 minutes; subsequent cycles: 6 mg/kg, infused over 30-60 minutes)
- interventionNames
- Drug: Exemestane
- Drug: Letrozole
- Drug: Anastrozole
- Drug: Leuprolide Acetate
- Drug: Pertuzumab
- Drug: Trastuzumab
Primary outcomes (1)
- measure
- Evidence of Pathological Response
- timeFrame
- One year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Ability to provide signed, written informed consent * Histologically or cytologically confirmed non-metastatic adenocarcinoma of the breast (stage I-II) * Candidate for curative-intent treatment * ER+ and/or PR+ and HER2-positive (Fluorescence In Situ Hybridization-positive or 3+ by Immunohistochemistry staining) * Life expectancy greater than 5 years * Left Ventricular Ejection Fraction \> 50% at baseline (within 30 days of day 0) * Eastern Cooperative Oncology Group performance status ≤2 * Absolute Neutrophil Count \>1000/µL * Platelets ≥50,000/µL * Hemoglobin \>8.0 g/dL, * Creatinine ≤3.0 x upper limit of normal (ULN) * Bilirubin ≤3.0 x ULN * Aspartate aminotransferase or Alanine aminotransferase \<5.0 x ULN * Negative serum pregnancy test for women \<12 months after the onset of menopause unless surgically sterilized * Agreement by women of childbearing potential and male participants with partners of childbearing potential to use a "highly effective", non-hormonal form of contraception or two "effective" forms of non-hormonal contraception by the patient and/or partner. Exclusion Criteria: * Active infection * Presence of known metastases (stage IV disease) * Pregnant or lactating women * Prior chemotherapy or radiation therapy for the primary breast cancer * Concomitant malignancies or previous malignancies within the last 5 years except adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. * History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias * Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary or metabolic disease including diabetes, wound healing disorders, ulcers or bone fractures) * Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start or anticipated need for major surgery during the course of study treatment * Current known infection with Human Immunodeficiency Virus (HIV), Hepatitis B virus (HBV) or Hepatitis C Virus (HCV) * Receipt of intravenous antibiotics for infection within 14 days prior to receiving study treatment * Current chronic daily treatment with corticosteroids (dose \>10 mg/day methylprednisolone equivalent) except inhaled steroids * Known hypersensitivity to any of the study drugs * Assessment by the investigator to be unable or unwilling to comply with the requirements of the protocol
References
Publications (0)
Data not yet available
No reference posted for this study.