A

Phase 1

• Conditions: Patients with HER2 positive disease.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-003702-27-FR
• Lead Sponsor: Assistance Publique – Hôpitaux de Paris (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-19
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

•Adult patients over 18 years
•PALB2 germline heterozygous mutation carrier, wild type BRCA1&2 affected with metastatic breast cancer in first metastatic treatment line or beyond
•Histologically or cytologically confirmed breast cancer with evidence of metastatic disease.
•Triple Negative breast cancer
•RH+/HER2- breast cancer; ER/PR breast cancer positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have a disease form that the treating physician believes to be inappropriate for endocrine therapy.
•Prior therapy with an anthracycline and a taxane in an adjuvant setting.
•Prior platinum allowed as long as no breast cancer progression occurred on treatment or if given in adjuvant/neoadjuvant setting, at least 12 months elapsed from last dose to study entry.
•ECOG performance status 0-2.
•Adequate bone marrow, kidney and liver function.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patients with HER2 positive disease.
•Untreated and/or uncontrolled brain metastases.
•Cytopenia, defined with the following thresholds: (i) PN < 1500; Platelet count< 100 000; Hb <9g
•Prior malignancy unless curatively treated and disease-free for > 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, DCIS or stage I grade 1 endometrial cancer allowed.
•Known HIV (Human Immunodeficiency Virus) infection.
•Pregnant or breast-feeding women.
•Lack of affiliation to a social security benefit plan (as a beneficiary or assignee)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified