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Alkylating agents

PaCT for Advanced Breast Cancer

Phase 2

Waitlist Available

Led By Clinton Yam

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients must have an intact evaluable primary tumor or biopsy proven axillary node involvement with at least 1.0 centimeter (cm) smallest dimension based on imaging after neoadjuvant anthracycline-based chemotherapy and prior to initiation of neoadjuvant chemotherapy under this protocol; baseline measurements and evaluations must be obtained within 4 weeks of registration to the study; all areas of disease should be recorded in order to assess response and uniformity of response to therapy

Triple-negative breast cancer defined as estrogen receptor (ER) < 10%; progesterone receptor (PR) < 10% by immunohistochemistry (IHC) and human epidermal growth factor receptor 2 (HER2) 0-1 positive (+) by IHC or 2+, fluorescence in situ hybridization (FISH) < 2, gene copy number < 4

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from enrollment to progression of disease (> 20% increase in tumor size) or death whichever comes first, assessed up to 2 years

Awards & highlights

Study Summary

This trialstudies if immunotherapy and chemotherapy can shrink TNBC before surgery.

Who is the study for?

This trial is for women with newly diagnosed triple negative breast cancer that hasn't spread beyond the breast or nearby lymph nodes. Participants must have had some prior chemotherapy, be in good physical condition (ECOG 0-1), and have adequate organ function. Men are excluded, as are pregnant or breastfeeding women, those unwilling to use contraception, anyone with a history of certain cancers within 5 years, and patients with specific medical conditions.Check my eligibility

What is being tested?

The study tests panitumumab combined with carboplatin and paclitaxel before surgery in treating locally advanced triple negative breast cancer. Panitumumab is an immunotherapy drug that may help the immune system fight cancer cells. Carboplatin and paclitaxel are chemotherapy drugs aimed at stopping tumor growth by killing or preventing cell division.See study design

What are the potential side effects?

Potential side effects include allergic reactions to medication components, nerve damage (neuropathy), blood disorders like low platelet count or neutrophil count leading to increased bleeding risk or infection risk respectively, liver issues indicated by elevated bilirubin levels, heart problems such as reduced heart function measured by LVEF.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor or affected lymph node is at least 1cm in size after initial chemotherapy.

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My breast cancer is triple-negative.

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I am fully active or have some restrictions but can still carry out light work.

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My kidneys are functioning well, with a creatinine clearance rate of 50 mL/min or higher.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from enrollment to progression of disease (> 20% increase in tumor size) or death whichever comes first, assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from enrollment to progression of disease (> 20% increase in tumor size) or death whichever comes first, assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from enrollment to progression of disease (> 20% increase in tumor size) or death whichever comes first, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pathologic compete response (pCR) (residual cancer burden [RCB]-0) or RCB-I response rates of patients with localized triple-negative breast cancer (TNBC) treated with panitumumab, carboplatin and paclitaxel (PaCT)

Secondary outcome measures

Changes of EGFR levels

Overall survival (OS)

Pathologic complete response (pCR) (residual cancer burden [RCB]-0) or RCB-I response rates of patients treated with panitumumab, carboplatin and paclitaxel (PaCT)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (panitumumab, paclitaxel, carboplatin)Experimental Treatment3 Interventions

Patients receive panitumumab IV over 30 minutes and paclitaxel IV over 30 minutes on days 1, 8, and 15. Patients also receive carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5380

Panitumumab

2020

Completed Phase 3

~6490