Endocrine therapy plus CDK4/6 inhibitor in first or second line for hormone receptor positive advanced breast cancer

Phase 1

• Conditions: hormone receptor positive advanced breast cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-002334-23-NL
• Lead Sponsor: Dutch Breast Cancer Research Group (BOOG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-01
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 1050

Inclusion Criteria

1. Adult women (= 18 years of age) with proven diagnosis of adenocarcinoma of the breast with loco-regional recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent and for whom chemotherapy is not clinically indicated.
2. Documentation of histologically or cytologically confirmed diagnosis of estrogen-receptor (ER) expression >10% and/or progesterone receptor (PR) expression >10% breast cancer based on local laboratory results.
3. Previously untreated with any systemic anti-cancer therapy for metastatic HR+ disease, with the exception of recently started (within 28 days of randomization) endocrine therapy. Special considerations: a) Previous systemic treatment for locoregional recurrent disease is not an exclusion criterion, provided that the intent was curative at the time of systemic therapy. b) In case of previous systemic treatment for oligometastatic disease, patients are not eligible for SONIA.
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 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 650

Exclusion Criteria

1. Patients with advanced, symptomatic, visceral spread, who are at risk of life-threatening complications in the short term.
2. Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease.
3. Prior neoadjuvant or adjuvant treatment with a non-steroidal aromatase inhibitor (i.e., anastrozole or letrozole) with disease recurrence while on or within 12 months of treatment.
4. Prior treatment with any CDK4/6 inhibitor.

Study & Design

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