Clinical trial in patients with advanced breast cancer (hormone receptor-positive, HER2-negative) receiving palbociclib and standard therapy with an aromatase inhibitor or fulvestrant after prior endocrine therapy.

Phase 1

• Conditions: The study population includes postmenopausal patients with advanced (locally recurrent, inoperable and/or metastatic), HR+, HER2- breast cancer. For peri-/premenopausal patients, endocrine therapy has to be combines with a luteinizing hormone-releasinghormone (LRHR) agonist.; MedDRA version: 21.1Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864; MedDRA version: 23.0Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-001603-32-DE
• Lead Sponsor: iOMEDICO AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-04
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 360

Inclusion Criteria

- Patients with proven diagnosis of advanced adenocarcinoma of the breast (locally advanced, inoperable or metastatic disease).
- Patients with hormone-receptor-positive (HR+) disease, defined as ER+ and/or PgR+
- Patients with human-epidermal-growth-factor-receptor-2-negative (HER2-) disease
- Pre-/perimenopausal women receiving concomitant therapy with an luteinizing hormone-releasing hormone (LHRH) agonist or postmenopausal status
- Patients scheduled for palliative treatment with the combination of palbociclib and letrozole for first- or later-line, anastrozole for first-line, exemestane for first-line, or fulvestrant for first-or later-line after prior endocrine failure.
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0-2

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 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

Exclusion Criteria

- Patient has received prior treatment with any CDK inhibitor
- Prior adjuvant therapy with the respective endocrine combination partner if last intake <12 months prior to entering the study
- Prior palliative therapy with the respective endocrine combination partner
- More than one palliative chemotherapy for patients in treatment group 5 (second or later line, Palbociclib and Letrozole) and group 6 (Second or leter line, Palbociclib and Fulvestrant after prior endocrine therapy)
- Patient has known, not-irradiated CNS metastases

Study & Design

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