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Alkylating agents

Chemotherapy Combinations for Triple-Negative Breast Cancer

Phase 3

Waitlist Available

Led By Vicente Valero

Research Sponsored by NRG Oncology

Eligibility Criteria Checklist

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

Must have

By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN2b, pN3a, or pN3b

The patient must have undergone either a mastectomy (total, skin-sparing, or nipple-sparing) or lumpectomy

Must not have

Intrinsic lung disease resulting in dyspnea

T4 tumors including inflammatory breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing two different chemotherapy combinations to treat triple negative breast cancer to see which is more effective.

Who is the study for?

This trial is for patients with triple-negative breast cancer who have good blood counts, no metastatic disease on imaging, and a performance status indicating they can care for themselves. They must not be pregnant or breastfeeding, haven't received certain cancer treatments before, and don't have other serious health issues that would interfere with the study.

What is being tested?

The trial is testing if adding carboplatin to a chemotherapy regimen of doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel improves outcomes in treating triple-negative breast cancer compared to the regimen without carboplatin.

What are the potential side effects?

Possible side effects include nausea, vomiting, hair loss, fatigue, increased risk of infection due to low blood cell counts (neutropenia), heart problems from doxorubicin hydrochloride, nerve damage from paclitaxel (neuropathy), and kidney function changes.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer has spread to nearby lymph nodes but not to distant parts of my body.

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I have had a mastectomy or lumpectomy.

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I have been diagnosed with a type of breast cancer called invasive adenocarcinoma.

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My cancer has not spread beyond nearby lymph nodes.

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My tumor is not HER2 positive.

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I have had surgery for breast cancer, either a mastectomy or lumpectomy.

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My lumpectomy surgery removed all visible cancer and pre-cancer.

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I am fully active or can carry out light work.

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My tumor is not driven by estrogen or progesterone.

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I have had a procedure to check the status of my lymph nodes.

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My heart's pumping ability is good, confirmed by a test within the last 3 months.

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My surgery removed all visible cancer from the breast area.

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My tumor is larger than 3.0 cm and has not spread to nearby lymph nodes.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My primary tumor is classified as stage T1 to T3.

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My last surgery was within the past 60 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a lung condition that makes it hard for me to breathe.

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My breast cancer is advanced (T4) or inflammatory.

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I have had breast cancer or DCIS on the same side before.

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I have been treated with anthracyclines or taxanes for cancer.

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My heart condition allows me to use the drugs in the treatment plan.

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I take 10 mg or more of corticosteroids daily.

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I am currently using hormone therapy.

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I have received chemotherapy for my current breast cancer diagnosis before being assigned to a treatment group.

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I was hospitalized for DKA or HHNS in the last year.

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I have active hepatitis B or C with abnormal liver tests.

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I have an ongoing infection or need long-term antibiotics.

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I cannot take corticosteroids due to my health condition.

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My cancer has spread to other parts of my body.

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I have a moderate to severe nervous system disorder.

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I have had breast cancer in both breasts, either at the same time or at different times.

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My blood pressure is not controlled by medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 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

IDFS

Secondary study objectives

BCFS

DRFI

Frequencies of adverse events categorized using the National Cancer Institute CTCAE v4.0

+2 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (AC-->WP + carboplatin)Experimental Treatment5 Interventions

Patients receive doxorubicin hydrochloride and cyclophosphamide as in Arm I. Patients then receive paclitaxel IV over 60 minutes on days 1, 8, and 15 and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (AC-->WP)Active Control4 Interventions

Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive paclitaxel IV over 60 minutes on day 1. Treatment repeats weekly for 12 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Doxorubicin Hydrochloride

2019

Completed Phase 3

~17860