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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until trial end, death, withdrawal of consent or lost to follow-up, assessed up to 60 months
Awards & highlights
AIPAC-003 Trial 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.Check my eligibility
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.See study design
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.
AIPAC-003 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have triple-negative breast cancer and am to receive paclitaxel without PD 1/PD-L1 therapy for metastatic disease.
Select...
My breast cancer is either hormone receptor positive or negative, and HER2 negative.
Select...
My HR+ breast cancer has worsened after endocrine therapy, and I need chemotherapy.
Select...
I am fully active or can carry out light work.
AIPAC-003 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until trial end, death, withdrawal of consent or lost to follow-up, assessed up to 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until trial end, death, withdrawal of consent or lost to follow-up, assessed up to 60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determination of Overall survival (OS)
Determination of the Optimal Biological Dose (OBD)
Duration of adverse events (AEs)
+7 moreSecondary outcome measures
Changes from baseline in quality of life (QOL) as assessed by questionnaire of European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30
Determination of Progression Free Survival (PFS), based on RECIST, v1.1
Evaluation of Objective Response Rate (ORR) based on RECIST v1.1
+6 moreAIPAC-003 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
~5380
Find a Location
Who is running the clinical trial?
Immutep S.A.S.Lead Sponsor
11 Previous Clinical Trials
842 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer returned less than a year after my last chemotherapy.I have triple-negative breast cancer and am to receive paclitaxel without PD 1/PD-L1 therapy for metastatic disease.My breast cancer responds to hormone therapy and I am eligible for such treatment.I have HR+ metastatic breast cancer and received less than one line of hormone therapy.My HR+ breast cancer has worsened after endocrine therapy, and I need chemotherapy.My breast cancer is either hormone receptor positive or negative, and HER2 negative.You are expected to live for at least three more months.I am fully active or can carry out light work.I have had chemotherapy for advanced breast cancer before.I have triple-negative breast cancer and am eligible for PD-1/PD-L1 therapy with chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: open label lead-in (phase 2): eftilagimod alpha 90mg + paclitaxel
- Group 2: Phase 3: placebo + paclitaxel
- Group 3: open label lead-in (phase 2): eftilagimod alpha 30mg + paclitaxel
- Group 4: Phase 3: eftilagimod alpha + paclitaxel
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still slots available to partake in this research endeavor?
"Per the information hosted on clinicaltrials.gov, this study is not currently enrolling individuals as it was last updated on February 17th 2023. On the other hand, there are 2262 additional trials that are actively recruiting patients right now."
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