The CORE Study (Chemotherapy or Endocrine Treatment first?) - CORE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-000986-20-DE

Enrollment

1500

Registered

2005-08-15

Start date

2005-12-14

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with advanced breast cancer

Interventions

Trade Name: Femara ® Product Name: Femara ® (Letrozole) Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Letrozole CAS Number: not avaliabl Current Sponsor code: not avaliable Other descri

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - histologically proven breast cancer - Er+ or PgR+ - postmenopausal status - female age =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - known HER2-positivity (3+ by immunohistochemistry or HER2 FISH/CISH +) - concomitant treatment with radiotherapy, endocrine, cytotoxic or experimental cancer therapy - presence of cerebral or leptomeningeal metastases - sclerotic bone-metastases only - previous or concurrent malignancies at other sites, except basal cell carcinoma and carcinoma cervicis uteri in situ (patients with bilateral breast cancer can be included) - patients with immediately life-threatening metastatic disease (CT first is recommended)

Design outcomes

Primary

Measure	Time frame
Main Objective: The overall objective of the present trial is to find the optimal sequence of endocrine and cytotoxic treatment in patients with advanced breast cancer potenially sensitive to both modalities. The primary endpoint is overall survival (OS) from day of randomisation. ;Secondary Objective: As secondary objective we will study the respons and progression pattern in the two treatment arms. This includes analyses of the respons to the first and second treatment modality, as well as various analyses of the times of first and second progression, TTP1 and TTP2. ;Primary end point(s): The primary endpoint is overall survival (OS) from day of randomisation. As secondary objective we will study the respons and progression pattern in the two treatment arms. This includes analyses of the respons to the first and second treatment modality, as well as various analyses of the times of first and second progression, TTP1 and TTP2.	—

Measure

Time frame

Main Objective: The overall objective of the present trial is to find the optimal sequence of endocrine and cytotoxic treatment in patients with advanced breast cancer potenially sensitive to both modalities. The primary endpoint is overall survival (OS) from day of randomisation. ;Secondary Objective: As secondary objective we will study the respons and progression pattern in the two treatment arms. This includes analyses of the respons to the first and second treatment modality, as well as various analyses of the times of first and second progression, TTP1 and TTP2. ;Primary end point(s): The primary endpoint is overall survival (OS) from day of randomisation. As secondary objective we will study the respons and progression pattern in the two treatment arms. This includes analyses of the respons to the first and second treatment modality, as well as various analyses of the times of first and second progression, TTP1 and TTP2.

—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026