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Alkylating agents

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

Phase 2

Waitlist Available

Led By Kari Wisinski, MD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Approved for 20 Other Conditions

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial tests a two-phase chemotherapy treatment for patients with triple-negative breast cancer. First, patients receive smaller doses of Carboplatin and Paclitaxel. Then, they get higher doses of Doxorubicin and Cyclophosphamide. The goal is to weaken and then aggressively kill the cancer cells. Carboplatin and Paclitaxel are commonly used in treating triple-negative breast cancer, often followed by anthracycline-based therapies like Doxorubicin and Cyclophosphamide.

Eligible Conditions

Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number and Percentage of Participants With Pathologic Complete Response (pCR) Rate

Secondary study objectives

Delays of Administered Chemotherapy

Number of Cycles of Chemotherapy Administered

Number of Treatment-related Toxicities Experienced by Participants

+3 more

Awards & Highlights

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Neoadjuvant ChemotherapyExperimental Treatment6 Interventions

Regimen A (cycles 1-4): Paclitaxel 80 mg/m2; administer intravenously on day 1, 8, 15 of cycles 1, 2, 3, 4 (every 3 weeks) Carboplatin AUC=2 (dose calculation by determining creatine clearance with Cockroft Gault using adjusted body weight); administer intravenously on day 1, 8, 15 of cycles 1, 2, 3, 4 (every 3 weeks) Regimen B (cycles 5-8): Doxorubicin 60 mg/m2; administer intravenously on day 1 of cycles 5, 6, 7, 8 (every 2 weeks) Cyclophosphamide 600 mg/m2; administer intravenously on day 1 of cycles 5, 6, 7, 8 (every 2 weeks) Pegfilgrastim (for use on Doxorubicin/Cyclophosphamide cycles only), filgrastim, or biosimilar support on day 2 - 3 of cycles 5, 6, 7, 8 (every 2 weeks) There is a one week break between the end of cycle 4 and the beginning of cycle 5. Regimen C: Surgical intervention for management of breast cancer diagnosis; procedure and timing as determined by surgical team.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pegfilgrastim

FDA approved

Cyclophosphamide

FDA approved

Doxorubicin

FDA approved

Filgrastim

FDA approved