Loading clinical trials...

Neoadjuvant Carbo/Paclitaxel Followed by Doxorubicin/Cyclophosphamide in Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Neoadjuvant Carbo/Paclitaxel Followed by Doxorubicin/Cyclophosphamide in Breast Cancer

A Phase II Study of Neoadjuvant Carboplatin/Paclitaxel Followed by Dose-Dense Doxorubicin/Cyclophosphamide in Patients With Hormone Receptor Negative, HER2 Receptor Negative Breast Cancer

NCT03301350•University of Wisconsin, Madison

View on ClinicalTrials.gov

Summary

This is a phase II single-arm, open-label, prospective study to evaluate the efficacy of the low dose weekly Carboplatin/Paclitaxel followed by dose-dense Doxorubicin/Cyclophosphamide in subjects with triple-negative breast cancer in neoadjuvant settings.

Eligibility

Age

18 - 74 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects must have histologically or cytologically confirmed invasive breast cancer which meets the following criteria:
•1. Estrogen Receptor (ER) and Progesterone Receptor (PR)-negative as defined by local standard clinical immunohistochemistry (IHC) \< 1%.
•2. HER2-negative using local standard testing. Negative is defined as IHC 0 or 1+ (if 2+, must reflex to ISH method). If ISH method is used, ratio \< 2 is considered negative.
•4. Any radiographic abnormal ipsilateral regional lymph nodes or any clinically concerning ipsilateral regional lymph nodes with the exception of internal mammary nodes should be sampled with percutaneous biopsy, but no sentinel axillary lymph node mapping/biopsy is allowed before chemotherapy. If clinically node negative (cNO), pre-chemotherapy ipsilateral sentinel axillary lymph node mapping/biopsy is not allowed.
•2. Candidate for neoadjuvant chemotherapy.
•3. Age \> 18 years and \< 75 years
•4. ECOG Performance Status \< 1.
•5. Left ventricular ejection fraction (LVEF) ≥ LLN (per institutional normal) determined by
•6. Adequate organ and marrow function as determined by study protocol
•7. Non Pregnant. Women of childbearing potential must have a negative pregnancy test (HCG serum or urine) within 30 days prior to study registration and to be repeated if not done within 7 days of starting chemotherapy.
+8 more criteria

Exclusion Criteria

•1. Prior chemotherapy or radiation therapy for invasive breast cancer within 6 months before registration.
•2. Prior investigational drugs or interventions for invasive breast cancer within 6 months before registration are not allowed. Prior participation in window-of-opportunity trials without therapeutic intent is allowed if intervention is no more than 3 weeks duration.
•3. Stage IV metastatic breast cancer
•4. History of allergic reactions attributed to compounds of similar chemical composition to chemotherapy to be used in this study.
•5. Breastfeeding women. Cytotoxic chemotherapy is drug with the potential for teratogenic or abortifacient effects. Due to unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cytotoxic chemotherapy, breastfeeding should be discontinued.
•6. Baseline peripheral neuropathy of severity \> grade 1
•7. Other invasive cancer diagnosis within the past 5 years other than non-melanoma skin cancer.
•8. Prior axillary lymph node dissection that preclude patient from surgical evaluation of axillary lymph node status.

Locations (6)

Swedish American Hospital

Rockford, Illinois, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Columbia St. Mary's Cancer Center

Milwaukee, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

ProHealth Care

Waukesha, Wisconsin, United States

Aspirus Regional Cancer Center Wausau

Wausau, Wisconsin, United States

Key Dates

Start Date

November 7, 2017

Primary Completion Date

March 23, 2020

Completion Date

February 7, 2022

Last Updated

February 13, 2026

Enrollment

ACTUAL participants

Conditions

Breast CancerTriple Negative Breast Cancer

Interventions

Carboplatin

DRUG

Paclitaxel

DRUG

Doxorubicin

DRUG

Cyclophosphamide

DRUG

Pegfilgrastim

DRUG

Filgrastim

DRUG

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

NCT05245812

Breast CancerHigh Risk of Breast Cancer

View study

RECRUITINGPHASE1

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

NCT05673200

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+2 more

View study

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: February 13, 2026Data 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 Carbo/Paclitaxel Followed by Doxorubicin/Cyclophosphamide in Breast Cancer

Inclusion Criteria

Exclusion Criteria

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

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

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

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