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NEOADjuvant Aromatase Inhibitor and Pertuzumab/Trastuzumab for Women With Breast Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2

NEOADjuvant Aromatase Inhibitor and Pertuzumab/Trastuzumab for Women With Breast Cancer

A Phase II Study of NEOADjuvant Aromatase Inhibitor and Pertuzumab/Trastuzumab (NEOADAPT)

NCT02689921•Midwestern Regional Medical Center

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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,
+5 more criteria

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
+3 more criteria

Locations (2)

Southeastern Regional Medical Center

Newnan, Georgia, United States

Cancer Treatment Centers of America at Midwestern Regional Medical Center

Zion, Illinois, United States

Key Dates

Start Date

April 1, 2016

Primary Completion Date

December 1, 2018

Completion Date

December 1, 2018

Last Updated

September 28, 2018

Enrollment

ACTUAL participants

Conditions

Breast Neoplasms

Interventions

Exemestane

DRUG

Letrozole

DRUG

Anastrozole

DRUG

Leuprolide Acetate

DRUG

Pertuzumab

DRUG

Trastuzumab

DRUG

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

NCT07191730

CardiotoxicityHeart Failure+2 more

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RECRUITINGPHASE2

Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)

NCT06797635

Breast NeoplasmsBreast Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 28, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

NEOADjuvant Aromatase Inhibitor and Pertuzumab/Trastuzumab for Women With Breast Cancer

Inclusion Criteria

Exclusion Criteria

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)

A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)

Evaluation of Clinical Efficacy of Augmented Reality (AR)-Based Breast Cancer Medical Imaging Solution (SKIA-Breast) Localization Method in Breast Cancer Patients

Dissemination of BREASTChoice AIM1-B

Role of Sodium-glucose Linked Transporter 2 (SGLT2) and Its Inhibitor Over CARdiotoxicity Induced by Anthracyclines and Breast Cancer Tumorigenesis SCARA-B