A Study to Evaluate the Efficacy and Toxicities of PLX038, in Patients With Locally Advanced or Metastatic Triple-negative Breast Cancer

Launched by INSTITUT CURIE · Nov 29, 2023

Keywords

ClinConnect Summary

This clinical trial is evaluating a new treatment called PLX038 for patients with a specific type of breast cancer known as triple-negative breast cancer. This cancer is referred to as "triple-negative" because it does not have three common markers (estrogen and progesterone receptors, and HER2) that are often targeted in breast cancer treatments. The study aims to see how effective PLX038 is in helping patients who have already received previous treatments but still have locally advanced or metastatic (spread to other parts of the body) disease.

To be eligible for the trial, participants must be at least 18 years old and have confirmed triple-negative breast cancer that is not curable with standard treatments. They should have had at least two previous chemotherapy treatments and need to be in reasonably good health, meaning they can perform daily activities without much difficulty. Participants can expect to receive PLX038 and will be closely monitored for how well the treatment works and if there are any side effects. It's important to note that the trial is currently recruiting participants, so those interested should talk to their healthcare provider about whether they qualify and if this study could be a good option for them.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Willing and able to comply with the protocol and provide written informed consent prior to study-specific screening procedures.
• • Age ≥ 18 years.
• • Females and males with cytologically or histologically confirmed breast carcinoma (either the primary or metastatic lesions).
• • Locally advanced or metastatic disease that is not amenable to curative treatment.
• • Triple negative breast cancer (both ER and PR \<10%, HER2-negative or HER2-low).
• • Measurable disease (per RECIST version 1.1).
• • Prior therapy (administered in the neoadjuvant, adjuvant and/or metastatic setting) with chemotherapy by an anthracycline, taxane and sacituzumab-govitecan (unless not medically appropriate or contraindicated for the patient).
• • Received a minimum of two prior cytotoxic chemotherapy regimens for locally advanced or metastatic breast cancer.
• • Patients with known gBRCA mutations must have received a PARP inhibitor in the metastatic setting.
• • Patients whose cancer has a CPS score ≥10 must have received prior pembrolizumab unless (i) contra-indicated (ii) CPS score or pembrolizumab not available at time of first line treatment start.
• • Resolution of chemotherapy and radiation therapy related toxicities to NCI-CTCAE version 5.0 Grade 1 or lower severity, except for stable sensory neuropathy (≤ Grade 2), alopecia (any grade), presence of clinically managed chronic autoimmune AEs from prior immune therapy.
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• * Adequate organ function (obtained within 14 days prior to treatment start) as evidenced by:
• • i. Absolute neutrophil count (ANC) ≥ 1.5 X 109/L; ii. Hemoglobin (Hgb) ≥ 9 g/dL; iii. Platelet count ≥ 100 X 109/L; iv. Bilirubin ≤ 1.5 X upper limit of normal (ULN), except for patients with a documented history of Gilbert's disease (≤ 2 X ULN); v. Alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 2.5 X ULN (for patients with liver metastases ≤ 5 X ULN); vi. Alkaline phosphatase (AP) ≤ 3 X ULN (for patients with liver metastases, ≤ 5 X ULN); vii. Serum creatinine ≤ 1.5 mg/dL (133 μmol/L) or calculated creatinine clearance ≥ 50 mL/min (using Cockcroft-Gault formula); viii. Women of childbearing potential (WCBP): negative serum pregnancy test.
• • Patients covered by social security or health insurance in compliance with the national legislation relating to biomedical research.
• Exclusion Criteria:
• • Patients who had a last dose of IV chemotherapy within 21 days, last dose of oral cytotoxic chemotherapy, radiotherapy, biological therapy, or investigational therapy within 14 days prior to treatment start.
• • Patients who had any major surgery within 28 days prior to inclusion.
• • Patients with chronic inflammatory bowel disease and/or bowel obstruction.
• • Concomitant use of other agents for the treatment of cancer or any investigational agent(s).
• • Brain metastases, unless local therapy was completed and use of corticosteroids for this indication discontinued for at least 3 weeks prior to inclusion. Signs or symptoms of brain metastases must be stable for at least 28 days prior to inclusion. No known progression of brain metastases (by imaging as assessed by RECIST) can have occurred. Patients with leptomeningeal disease or meningeal carcinomatosis are excluded.
• • Women who are either pregnant, lactating, planning to get pregnant.
• • Patients receiving pharmacotherapy for hepatitis B or C, tuberculosis, or HIV.
• • Patients with known liver disease diagnosed with Child-Pugh A or higher cirrhosis.
• • Prior stage III or IV malignancy (other than breast cancer).
• • Severe/uncontrolled intercurrent illness within the previous 28 days prior to inclusion.
• • Significant known cardiovascular impairment (NYHA CHF \> grade 2, unstable angina, myocardial infarction within the previous 6 months prior to inclusion, or existing unstable cardiac arrhythmia).
• • Any other significant medical, psychological, social or geographic conditions that in the opinion of the Investigator would impair study participation or cooperation.
• • Patients deprived of their liberty or under guardianship.