A study comparing two treatments for advanced ER-positive breast cancer: continuing a combination therapy versus switching to hormone therapy alone after initial treatment stops working.

A phase II double-arm study of the switch of Endocrine therapy with the continuation of CDK4/6 inhibitor vs. switch of endocrine therapy alone as second-line and beyond in ER-positive breast cancer patients ( SECURE study). - SECURE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/068274

Enrollment

128

Registered

2024-06-03

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Fulvestrant/Letrozole/exemestane + Tamoxifen +/- leuprolide and Ribociclib/ Palbociclib/ Abemaciclib.: Ribociclib will be administered orally at 600 mg PO for 21 consecutive days with 7

Eligibility

Inclusion criteria

Inclusion criteria: a. Women of age 18 years or older with locally advanced, unresectable, or metastatic breast cancer. b. ECOG 0 to 2 and adequate bone marrow, hepatic, and renal function and willing to give informed consent. Patients could have either measurable or non-measurable diseases defined by RECIST version 1.1. c. Tumors that are positive for the ER and/or progesterone receptor are defined as greater than 1percent. Human epidermal growth factor receptor 2 (HER2) status should be negative. d. Patients may have received (neo)adjuvant chemotherapy ( greater than 12 months since completion of chemotherapy) and any duration of adjuvant ET (less than 4 weeks of ET for MBC before trial registration).

Exclusion criteria

Exclusion criteria: a. Patients with more than 1 prior therapy for MBC. Known brain or leptomeningeal metastasis or life expectancy less than 12 weeks or serious or uncontrolled concurrent medical illness b. History of second primary malignancies.

Design outcomes

Primary

Measure	Time frame
To evaluate Progression-free survival (PFS) at 6 months of endocrine therapy with the continuation of CDK4/6 inhibitors vs. endocrine therapy alone as second-line and beyond therapy in advanced metastatic breast cancer. Timepoint: Analysis at 1. Baseline 2. every 3 cycle(+/- 1 cycle) till diesease progression or till patient on trial.	—

Secondary

Measure	Time frame
To evaluate Overall Survival (OS) of endocrine therapy with the continuation of CDK4/6 inhibitors vs. endocrine therapy alone as second-line and beyond therapy in advanced metastatic breast cancer. To evaluate the tolerability of endocrine therapy with the continuation of CDK4/6 inhibitors vs. endocrine therapy alone as second-line and beyond therapy in advanced metastatic breast cancer. To evaluate Progression-free survival (PFS) at 3 and 12 months of endocrine therapy with the continuation of CDK4/6 inhibitors vs. endocrine therapy alone as second-line and beyond therapy in advanced metastatic breast cancer. To evaluate the Quality of life (QOL) of endocrine therapy with the continuation of CDK4/6 inhibitors vs. endocrine therapy alone as second-line and beyond therapy in advanced metastatic breast cancer.Timepoint: To evaluate Progression-free survival (PFS) at 3 and 12 months of endocrine therapy	—

Measure

Time frame

To evaluate Overall Survival (OS) of endocrine therapy with the continuation of CDK4/6 inhibitors vs. endocrine therapy alone as second-line and beyond therapy in advanced metastatic breast cancer. To evaluate the tolerability of endocrine therapy with the continuation of CDK4/6 inhibitors vs. endocrine therapy alone as second-line and beyond therapy in advanced metastatic breast cancer. To evaluate Progression-free survival (PFS) at 3 and 12 months of endocrine therapy with the continuation of CDK4/6 inhibitors vs. endocrine therapy alone as second-line and beyond therapy in advanced metastatic breast cancer. To evaluate the Quality of life (QOL) of endocrine therapy with the continuation of CDK4/6 inhibitors vs. endocrine therapy alone as second-line and beyond therapy in advanced metastatic breast cancer.Timepoint: To evaluate Progression-free survival (PFS) at 3 and 12 months of endocrine therapy

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Countries

India

Contacts

Public ContactDr Sushmita Rath

Tata Memorial Hospital

sushmitarath73@gmail.com9869154396

Outcome results

None listed

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