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Efficacy and Safety of IPI-504 With Trastuzumab Pretreated, Locally Advanced or Metastatic HER2 Positive Breast Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Efficacy and Safety of IPI-504 With Trastuzumab Pretreated, Locally Advanced or Metastatic HER2 Positive Breast Cancer

A Phase 2 Multicenter Study Evaluating the Efficacy and Safety of IPI-504 in Combination With Trastuzumab in Patients With Pretreated, Locally Advanced or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer

NCT00817362•Infinity Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to see if IPI-504 in combination with trastuzamab is an effective treatment in HER2 positive metastatic breast cancer

Detailed Description

Recent clinical data has demonstrated that even in heavily pretreated patients with trastuzumab-refractory HER-2 positive breast cancer, targeting HER2 is efficacious. IPI-504 is an HSP90 inhibitor and is chemically related to 17-AAG and it has been studied in a clinical trial in combination with trastuzamab and a response rate of 26% (7/27) was demonstrated in patients with pretreated, HER2-positive breast cancer. These data provide a strong scientific rationale for clinical testing of IPI-504 plus trastuzumab in patients with pretreated, locally advanced or metastatic HER2-positive breast cancer

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Locally advanced/metastatic breast cancer.
•HER2-expressing primary or metastatic tumor
•Two prior regimens with HER2. Trastuzumab must have been given. No limit to prior therapies
•Measurable disease with RECIST 1.1
•Clinical progression
•LVEF WNL
•ECOG 0 or 1
•Last dose of chemotherapy, radiotherapy, surgery, ablative therapy, tyrosine kinase inhibitor, ≥2 weeks
•Administration of biological therapy ≥4 weeks
•Last dose of trastuzumab must be ≥1, or ≥3 weeks prior to start, if previously administered on an every 3 week schedule.
+12 more criteria

Exclusion Criteria

•Prior treatment with Hsp90 inhibitor.
•Grade 4 AE secondary to trastuzumab. Grade 3/4 infusion reactions or Grade 3/4 symptomatic heart failure
•Medication/food that is a CYP3A inhibitor or inducer.
•Hx 6 months: cardiac disease - acute coronary syndrome or unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, cirrhotic liver disease, cerebrovascular accident or significant co-morbid condition
•Grade 3 or 4 hemorrhagic event within 6 months.
•HIV positivity
•Baseline QT corrected, QTcF \>470 ms
•Sinus bradycardia \<50 bpm Secondary to pharmacologic therapy may enroll if stopping therapy normalizes heart rate.
•Malignancies within 3 years other than non-melanomatous skin cancers, non-muscle-invasive bladder cancer and carcinoma in situ of cervix.
•Active keratitis or keratoconjunctivitis
+1 more criteria

Locations (11)

Comprehensive Cancer Center at Desert Regional Medical Center

Palm Springs, California, United States

Boca Raton Comphrensive Cancer Care

Boca Raton, Florida, United States

Florida Cancer Research Institute

Davie, Florida, United States

Peachtree Hematology-Oncology Consultants, P.C.

Atlanta, Georgia, United States

Medical College of Georgia Cancer Center

Augusta, Georgia, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Weill Cornell Breast Center

New York, New York, United States

West Cancer Clinic

Memphis, Tennessee, United States

US Oncology

Dallas, Texas, United States

Key Dates

Start Date

March 1, 2009

Primary Completion Date

August 1, 2010

Completion Date

May 1, 2011

Last Updated

December 11, 2012

Enrollment

ACTUAL participants

Conditions

Breast CancerHER2 Positive Breast CancerMetastatic Breast CancerCancer of the Breast

Interventions

IPI-504

DRUG

Trastuzumab

DRUG

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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: December 11, 2012Data 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

Efficacy and Safety of IPI-504 With Trastuzumab Pretreated, Locally Advanced or Metastatic HER2 Positive Breast Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer