| CTRI Number |
CTRI/2024/06/068274 [Registered on: 03/06/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Progression free survival] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
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. |
|
Scientific Title of Study
|
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). |
| Trial Acronym |
SECURE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sushmita Rath |
| Designation |
Professor of Medical Oncology Department |
| Affiliation |
Tata Memorial Hospital |
| Address |
Dept. Medical Oncology, Homi Bhabha Block, Room no. 1005, Tata Memorial Hospital, Dr. Ernest Borges Road, Parel, Mumbai, MAHARASHTRA, India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869154396 |
| Fax |
02224177201 |
| Email |
sushmitarath73@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushmita Rath |
| Designation |
Professor of Medical Oncology Department |
| Affiliation |
Tata Memorial Hospital |
| Address |
Dept. Medical Oncology, Homi Bhabha Block, Room no. 1005, Tata Memorial Hospital, Dr. Ernest Borges Road, Parel, Mumbai, MAHARASHTRA, India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869154396 |
| Fax |
02224177201 |
| Email |
sushmitarath73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushmita Rath |
| Designation |
Professor of Medical Oncology Department |
| Affiliation |
Tata Memorial Hospital |
| Address |
Dept. Medical Oncology, Homi Bhabha Block, Room no. 1005, Tata Memorial Hospital, Dr. Ernest Borges Road, Parel, Mumbai, MAHARASHTRA, India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869154396 |
| Fax |
02224177201 |
| Email |
sushmitarath73@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Tata Memorial Centre, Homi Bhabha Biulding,Dr. Borges Road,Parel, Mumbai-400012, Maharashtra, India. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sushmita Rath |
Tata Memorial Hospital |
Dep. Medical Oncology, Tata Memorial Centre, Homi Bhabha Biulding,Room no. 1005, Dr.Ernest Borges Road,Parel, Mumbai-400012, Maharashtra, India.
Mumbai
MAHARASHTRA |
9869154396
02224177201
sushmitarath73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital Institutional Ethics Committee I |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fulvestrant/Letrozole/exemestane + Tamoxifen +/- Leuprolide alone |
Fulvestrant administered IM as a 250mg + 250mg on day 14, day 28 and then monthly.
|
| Intervention |
Fulvestrant/Letrozole/exemestane + Tamoxifen +/- leuprolide and Ribociclib/
Palbociclib/ Abemaciclib. |
Ribociclib will be administered orally at 600 mg PO for 21 consecutive days with 7 days
back. Palbociclib will be given orally at 125 mg PO dose for 21 consecutive days with
7 days gap. Abemaciclib will be given orally at 150 mg PO BD dose continuously. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
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). |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
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.
|
Analysis at
1. Baseline
2. every 3 cycle(+/- 1 cycle) till diesease progression or till patient on trial. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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. |
To evaluate Progression-free survival (PFS) at 3 and 12 months of endocrine therapy |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
12/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Treatment studies /Interventional Studies :
Randomized Controlled Trial
Open Labeled
Study Design
Type of study Double-arm prospective phase II open-label.
Patient number - 64 patients in each arm
Time schedule - Recruitment will commence post institutional review board (IRB) clearance
of the proposed study. The study will start in TMH once approval is obtained from the IRB. Recruitment in other centers will start after individual institution clearance for the study is
obtained.
Approximate accrual time - 36 months.
Approximate time for follow-up - 6 months post accrual of last patients.
Final study report – approximately 42 months post the beginning of the study.
Number of centres - 1
Primary Endpoints : 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. Secondary Endpoints : 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.
Eligibility Inclusion Criteria : a. Women of age 18 years or older with locally advanced, unresectable, or metastatic breast cancer. b. ECOG 0 - 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 > 1%. Human epidermal
growth factor receptor 2 (HER2) status should be negative. d. Patients may have received (neo)adjuvant chemotherapy ( > 12 months since completion of
chemotherapy) and any duration of adjuvant ET (< 4 weeks of ET for MBC before trial registration).
Exclusion Criteria : a. Patients with more than 1 prior therapy for MBC. Known brain or leptomeningeal metastasis or life
expectancy < 12 weeks or serious or uncontrolled concurrent medical illness b. History of second primary malignancies.
Study methodology: Participants fulfilling all in-/exclusion criteria, and having provided written informed consent on the
approved informed consent form are eligible for participation in the study. They would then be
enrolled in the study. Further, the enrolled Participants will be randomized into a 1:1 ratio into arms
Arm A standard treatment + continuation of CDK4/6 inhibitor
Arm B standard treatment alone
Post-randomization participants will receive the treatment as detailed below.
Treatment
Patients will be randomized to either Arm A or Arm B
ARM A
Fulvestrant/Letrozole/exemestane + Ribociclib/ Palbociclib/ Abemaciclib. Ribociclib will be administered at 600 mg PO for 21 consecutive days with 7 days back.
Palbociclib will be given at 125 mg PO dose for 21 consecutive days with 7 days gap.
Abemaciclib will be given at 150 mg PO BD dose continuously.
ARM B
Fulvestrant/Letrozole/exemestane alone |