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Immunomodulator

Chemo-Immunotherapy for Breast Cancer (AIPAC-003 Trial)

Phase 2 & 3

Recruiting

Research Sponsored by Immutep S.A.S.

Eligibility Criteria Checklist

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

Must have

Participants with HR- MBC (i.e. triple-negative breast cancer [TNBC]) who are indicated to receive paclitaxel chemotherapy without PD 1/PD-L1 therapy in the 1st line setting for metastatic disease

Metastatic HR+ positive (estrogen receptor positive and/or progesterone receptor positive) or hormone receptor negative (HR˗), and HER2-neg breast adenocarcinoma, histologically proven by biopsy on the last available tumor tissue

Must not have

Participants with HR+ MBC who have received <1 line of ET based therapy in the metastatic setting

Prior chemotherapy for metastatic breast adenocarcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 13 months

Summary

This trial will compare a chemo-immunotherapy to chemotherapy alone to see if it can better treat metastatic breast cancer.

Who is the study for?

This trial is for individuals with metastatic breast cancer who are set to receive paclitaxel chemotherapy. It's open to those with triple-negative breast cancer not getting PD-1/PD-L1 therapy, or hormone receptor-positive patients after at least one endocrine therapy. Participants should be in good physical condition (ECOG 0-1) and expected to live more than three months.

What is being tested?

Researchers are testing eftilagimod alpha (efti), an immunotherapy drug, combined with standard paclitaxel chemotherapy against placebo plus chemotherapy. They aim to find the best dose of efti and see if it improves survival rates compared to chemotherapy alone in two phases: chemo-immunotherapy followed by immunotherapy.

What are the potential side effects?

Possible side effects include reactions related to the immune system due to eftilagimod alpha, as well as typical side effects from paclitaxel like hair loss, neuropathy, fatigue, nausea, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

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

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I have triple-negative breast cancer and am to receive paclitaxel without PD 1/PD-L1 therapy for metastatic disease.

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My breast cancer is either hormone receptor positive or negative, and HER2 negative.

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My HR+ breast cancer has worsened after endocrine therapy, and I need chemotherapy.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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I have HR+ metastatic breast cancer and received less than one line of hormone therapy.

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I have had chemotherapy for advanced breast cancer before.

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I have triple-negative breast cancer and am eligible for PD-1/PD-L1 therapy with chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 13 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 13 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 13 months for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Changes from baseline in quality of life (QOL) as assessed by questionnaire of European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: open label lead-in (phase 2): eftilagimod alpha 90mg + paclitaxelExperimental Treatment2 Interventions

eftilagimod alpha 90mg s.c. + 80mg/m\^2 paclitaxel i.v. (same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase. The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance. The IO-phase is planned to follow the chemo-IO phase. A maximum of 13 cycles (approx. 12 months) of treatment is planned.

Group II: open label lead-in (phase 2): eftilagimod alpha 30mg + paclitaxelExperimental Treatment2 Interventions

eftilagimod alpha 30mg s.c. + 80mg/m\^2 paclitaxel i.v. (same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase. The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance. The IO-phase is planned to follow the chemo-IO phase. A maximum of 13 cycles (approx. 12 months) of treatment is planned.

Group III: Phase 3: eftilagimod alpha + paclitaxelExperimental Treatment2 Interventions

eftilagimod alpha s.c. (OBD) + 80mg/m\^2 paclitaxel i.v. (same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase. The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance. The IO-phase is planned to follow the chemo-IO phase. A maximum of 13 cycles (approx. 12 months) of treatment is planned.

Group IV: Phase 3: placebo + paclitaxelPlacebo Group2 Interventions

placebo s.c. + 80mg/m\^2 paclitaxel i.v. (same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase. The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance. The IO-phase is planned to follow the chemo-IO phase. A maximum of 13 cycles (approx. 12 months) of treatment is planned.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5370

0 / 7Eligibility criteria met