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Phase II Breast Ca Carboplatin + Paclitaxel With Pertuzumab + Trastuzumab or Bevacizumab | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Phase II Breast Ca Carboplatin + Paclitaxel With Pertuzumab + Trastuzumab or Bevacizumab

A Phase II Study of Breast Cancer Treatment Using Weekly Carboplatin + Paclitaxel With Pertuzumab + Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Neoadjuvant Setting

NCT02436993•University of California, Irvine

View on ClinicalTrials.gov

Summary

The purpose of this phase II is to study the efficacy and toxicity of carboplatin and paclitaxel with pertuzumab and trastuzumab in HER2 positive and carboplatin and paclitaxel with bevacizumab in HER2 negative in the neoadjuvant setting for the treatment of breast cancer.

Detailed Description

OBJECTIVES The study component is to evaluate the treatment response and toxicity of the protocol. Objectives for treatment study component: 1.1 To estimate 2-year progression-free survival in patients with breast cancer with tumor more than 1 cm and/or with clinically detected lymph node treated with neoadjuvant weekly Carboplatin and Paclitaxel combined with Trastuzumab + Pertuzumab in HER2-positive disease or with Bevacizumab in HER2-negative disease. 1.2 To measure the microscopic complete pathological response (pCR) rates defined as ypT0 or ypTis tumors in patients treated with this regimen in the neoadjuvant setting. 1.3 To assess complete clinical response (cCR) rates after treatment by physical exam and imaging tests (ultrasonography, mammography, or magnetic resonance imaging) clinical objective response rate (by Response Evaluation Criteria In Solid Tumors (RECIST)) 1.4 To determine the toxicity of this regimen. 1.5 To determine treatment adherence and delivered dose intensity of this regimen. 1.6 To assess the correlation between pCR and cCR. 1.7 To determine the rate of breast conservation following neoadjuvant therapy. 1.8 Determine treatment efficacy according to subgroups defined according to stage and receptor status.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Histologically proven unilateral or bilateral primary breast carcinoma. (In case of bilateral cancer, the investigator has to decide prospectively which side will be evaluated for the primary endpoint.)
•2. Tumor size is clinically at least 1 cm in greatest diameter (palpable or by imaging) and/or with involved lymph node. In case of inflammatory disease, the extent of inflammation may be the measurable lesion.
•3. Documentation of inflammatory breast cancer
•4. Woman age \> or = 18
•5. Performance status of 0-2 by Eastern Cooperative Oncology Group (ECOG) criteria
•6. Known HER2 status
•7. Normal cardiac function must be documented within 90 days prior to registration either via an ECHO or MUGA or per physician's review of symptoms and medical history. If an ECHO is performed as standard of care, the ejection fraction must be above the normal limit of the institution.. If not available in the medical chart, the ECHOs or MUGAs are not required to be repeated for research purposes.
•a. Date of Echo or multigated acquisition (MUGA) (within 90 days) if performed
•8. Staging work-up prior to registration
•1. Date of physical examination (within 90 days)
+18 more criteria

Exclusion Criteria

•11. Evidence of distant metastasis. If radiographic suspicion of distant metastatic site, a negative biopsy must be available in the medical record. If not available in the medical record, the subject may be included and a confirmatory biopsy is not required to be performed for research purposes.
•12. Known or suspected congestive heart failure, angina pectoris requiring antianginal medication, or other clinically significant cardiac condition.
•13. Pregnant or nursing women may not participate due to the possibility of harm to fetus or nursing infants from this treatment regimen. Women of childbearing potential may not participate unless they have agreed to use an adequate contraceptive method throughout study treatment and for one month after completion of treatment.
•14. Male patients
•15. Pre-existing peripheral neuropathy of severity grade ≥ 2 (limiting instrumental activities of daily living).
•16. Incomplete wound healing.
•17. Active and significant bleeding
•18. Known allergy, hypersensitivity or prior infusion reaction to one or more of the therapies incorporated into this treatment protocol.
•19. Bone marrow depression or hematologic parameters in the range that would increase the risk for severe bleeding.

Locations (1)

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Key Dates

Start Date

April 1, 2015

Primary Completion Date

November 1, 2023

Completion Date

December 1, 2036

Last Updated

July 14, 2025

Enrollment

120

ACTUAL participants

Conditions

Breast Carcinoma

Interventions

Carboplatin

DRUG

Paclitaxel

DRUG

Bevacizumab

DRUG

Trastuzumab

DRUG

Pertuzumab

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: July 14, 2025Data 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

Phase II Breast Ca Carboplatin + Paclitaxel With Pertuzumab + Trastuzumab or Bevacizumab

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

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

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

Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform