| CTRI Number |
CTRI/2025/12/098383 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
02/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
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Drug |
| Study Design |
Other |
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Public Title of Study
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A Phase 3 Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in Adult Patients With Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer Whose Disease Progressed After a Previous Treatment.
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Scientific Title of Study
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AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER, PHASE
3 STUDY OF PF-07248144 PLUS FULVESTRANT COMPARED TO
INVESTIGATOR’S CHOICE OF THERAPY IN ADULT PARTICIPANTS WITH
HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE
ADVANCED/METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED
AFTER PRIOR CDK4/6 INHIBITOR-BASED THERAPY |
| Trial Acronym |
NIL |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| C4551002, Final Protocol, 07 April 2025 |
Protocol Number |
| NCT07062965 |
ClinicalTrials.gov |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
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| Name |
Dr Seema Pai |
| Designation |
Senior Director Clinical Site Operations – India Cluster |
| Affiliation |
Pfizer Limited |
| Address |
The Capital, 1802/1901,
Plot No. C - 70, G Block, Bandra Kurla Complex,
Bandra (East)
Mumbai
MAHARASHTRA
400051
India |
| Phone |
912266932000 |
| Fax |
912226540274 |
| Email |
seema.pai@pfizer.com |
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Details of Contact Person
Public Query
|
| Name |
Dr Seema Pai |
| Designation |
Senior Director Clinical Site Operations – India Cluster |
| Affiliation |
Pfizer Limited |
| Address |
The Capital, 1802/1901,
Plot No. C - 70, G Block, Bandra Kurla Complex,
Bandra (East)
Mumbai
MAHARASHTRA
400051
India |
| Phone |
912266932000 |
| Fax |
912226540274 |
| Email |
seema.pai@pfizer.com |
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Source of Monetary or Material Support
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| Pfizer Inc.
66, Husdon Boulevard East, New York, NY 10001, United States |
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Primary Sponsor
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| Name |
Pfizer Inc. |
| Address |
66, Husdon Boulevard East, New York, NY 10001, United States |
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
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| Name |
Address |
| Pfizer Limited |
The Capital, 1802/1901,
Plot No. C - 70, G Block, Bandra Kurla Complex,
Bandra (East), Mumbai 400 051
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Countries of Recruitment
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Argentina
Australia
Belgium
Brazil
Bulgaria
Canada
China
Czech Republic
Finland
France
Germany
Greece
Hungary
India
Israel
Italy
Japan
Mexico
Netherlands
New Zealand
Poland
Republic of Korea
Slovakia
South Africa
Spain
Sweden
Taiwan
Turkey
United Kingdom
United States of America |
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Sites of Study
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| No of Sites = 13 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shailesh Bondarde |
Apex wellness Hospital |
Survey no 799, Plot no, 187,Govind Nagar, Behind
Prakash Petrol Pump, Nashik
422009, Maharashtra, India
Nashik
MAHARASHTRA |
9822012427
shaileshbondarde1971@gmail.com |
| Dr Priya Tiwari |
Artemis Hospital |
Sector-51,
Gurgaon, Haryana – 122001,
India.
Gurgaon
HARYANA |
8377828241
priya.tiwari@artemishospitals.com |
| Dr Nirmal Raut |
Bhaktivedanta Hospital and Research Institute |
Medical
Research Department, 3rd
Floor, Srishti Complex,
Bhaktivedanta Swami Marg,
Mira Road (E), Thane
401107, Maharashtra, India
Thane
MAHARASHTRA |
9930398156
pinirmal123@gmail.com |
| Dr Kalyan Kusum Mukherjee |
Chittaranjan National Cancer Institute |
37, S. P. Mukherjee Road,
Kalighat P.O, Kolkata- 700
026, West Bengal, India.
Kolkata
WEST BENGAL |
9830115905
kkmukherjee4u@hotmail.com |
| Dr Soumya Panda |
Department of Medical Oncology, Institute of Medical sciences (IMS) & SUM Hospital |
K-8, Kalinga
Nagar, Ghatikia, Khandagiri
Bhubaneswar, Odisha, India-
751003
Khordha
ORISSA |
8895370579
ssp_scb@yahoo.com |
| Dr Ajay Gogia |
Dr. BRA IRCH, All India Institute of Medical Sciences (AIIMS) |
Ansari Nagar East,
New Delhi-110029
New Delhi
DELHI |
9013000642
ajaygogia@gmail.com |
| Dr Raj Nagarkar |
HCG Manavata Cancer Centre |
Behind Shivang Auto,
Mumbai Naka, Nashik
422001, Maharashtra, India.
Nashik
MAHARASHTRA |
9823061929
drraj@manavatacancercentre.com |
| Dr Anshul Agarwal |
Nirmal Hospital Pvt Ltd. |
Ring Road, Surat, Gujarat,
India, 395002
Surat
GUJARAT |
9969465723
dranshulragarwal@gmail.com |
| Dr Sandip Jasuja |
R. K. Birla Cancer Center, SMS Medical College & Attached Hospitals |
J.L.N.
Marg, Jaipur, Rajasthan
302004, India
Jaipur
RAJASTHAN |
9660121475
sandeepjasuja@gmail.com |
| Dr Tushar Patil |
Sahyadri Super Speciality Hospital Deccan |
Plot no 30C,
Erandawane, Karve Road,
Pune 411004, Maharashtra,
India
Pune
MAHARASHTRA |
9552522556
tussipats@hotmail.com |
| Dr Satheesh C T |
Spandana Oncology Centre |
No 919, New No 68, 28th
Main Road, 9th Block,
Jayanagar, Bangalore,
Karnataka, 560069, India
Bangalore
KARNATAKA |
9242698750
drsatheeshct@gmail.com |
| Dr Sudeep Gupta |
Tata Memorial Centre |
Tata Memorial Hospital,
Dr. Ernest Borges Marg,
Parel (E), Mumbai – 400012,
Maharashtra, India
Mumbai
MAHARASHTRA |
98212 98642
sudeepgupta04@yahoo.com |
| Dr Kaushal Kalra |
Vardhman Mahavir Medical College and Safdarjung Hospital, |
Department of
Medical oncology, OLD SIC,
Ansari Nagar, Opp AIIMS,
New Delhi-110029, India.
New Delhi
DELHI |
9968663394
kaushalkalra@yahoo.com |
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Details of Ethics Committee
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| No of Ethics Committees= 13 |
| Name of Committee |
Approval Status |
| Apex Wellness Ethics Committee |
Approved |
| Artemis Health Sciences IEC |
Approved |
| Bhaktivedanta Hospital Ethics Committee. |
Approved |
| Ethics Committee S.M.S. Medical College and Attached Hospitals |
Submittted/Under Review |
| IEC for Spandana Oncology Centre |
Approved |
| Institute Ethics committee |
Submittted/Under Review |
| Institutional Ethics Committee - II |
Submittted/Under Review |
| Institutional Ethics Committee Chittaranjan National Cancer Institute |
Submittted/Under Review |
| Institutional Ethics Committee VMMC and SJH |
Submittted/Under Review |
| Institutional Ethics Committee, IMS & SUM Hospital |
Submittted/Under Review |
| Manavata Clinical Research Institute Ethics Committee |
Submittted/Under Review |
| NIRMAL HOSPITAL ETHICS COMMITTEE |
Approved |
| Sahyadri Hospitals Private Limited Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C501||Malignant neoplasm of central portion of breast, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Active Comparator: Arm B: Everolimus plus endocrine therapy |
Everolimus tablet taken by mouth plus investigators choice of endocrine therapy of Exemestane tablet taken by mouth or Fulvestrant taken as a shot into the muscle. |
| Intervention |
Experimental: Arm A: PF-07248144 plus Fulvestrant |
PF-07248144 tablet taken by mouth plus fulvestrant taken as a shot into the muscle. |
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
1. Confirmed diagnosis of HR-positive HER2-negative breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.
2. Prior CDK4/6 inhibitor therapy in combination with endocrine therapy in advance metastatic setting or in adjuvant setting with documented progression during or within 12 months after the last dose of CDK4/6i.
3. Participants are eligible if they previously received CDK4/6i or ET as a monotherapy, or in combination for rechallenge therapy in the advance or metastatic setting; have received prior therapy targeting estrogen receptor 1 (ESR1) or breast cancer gene (BRCA)1/2.
4. Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease
5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1. |
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| ExclusionCriteria |
| Details |
Exclusion Criteria:
1. Documented detectable PIK3CA/AKT1/PTEN alterations in tissue
2. Received greater than two prior lines of systemic therapy in the advance or metastatic setting
3. Had received any prior chemotherapy, including antibody drug conjugates (ADCs), in advance or metastatic setting. Participants who have previously received chemotherapy in the (neo)adjuvant setting are not excluded from the study.
4. Any medical or psychiatric condition that may increase the risk of study participation or make the participant inappropriate for the study.
5. Renal impairment, hepatic dysfunction, or hematologic abnormalities. |
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Method of Generating Random Sequence
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Other |
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Method of Concealment
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Other |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| Progression Free Survival (PFS) as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
From the date of randomization until disease progression or death due to any cause (up to approximately 2 years) |
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Secondary Outcome
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| Outcome |
TimePoints |
| Overall Survival (OS) |
From the date of randomization until death due to any cause (up to approximately 5 years). |
| Number of Participants with Objective Response (OR) by blinded independent central review (BICR) |
From the date of randomization until disease progression or death due to any cause (up to approximately 2 years) |
| Duration of Response (DoR) as defined by BICR |
From the date of the first objective (PR or CR) response (every 8 weeks during the first 48 weeks and then every 12 week) up to approximately 2 years. |
| Number of Participants With Clinical Benefit Response (CBR) by BICR |
From randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) up to approximately 2 years. |
| Number or Patients with Adverse Events (AEs) by Type |
From screening until 28 days after the last dose, to approximately 5 years |
| Number or Patients with AEs by Incidence |
From screening until 28 days after the last dose, to approximately 5 years |
| Number or Patients with AEs by Seriousness |
From screening until 28 days after the last dose, to approximately 5 years |
| Number or Patients with AEs by relationship to study interventions |
From screening until 28 days after the last dose, to approximately 5 years |
| Number of Participants With Abnormal Electrocardiogram (ECG; Arm A and B) |
From screening until 28 days after the last dose, to approximately 5 years |
| Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval (Arm A only) |
0h pre-dose on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, and Cycle 3 Day 1; additional 4 hrs post dose on Cycle 1 Day 15 and Cycle 2 Day 1 |
| Number of Participants With Laboratory Test Abnormalities |
From screening until 28 days after the last dose, to approximately 5 years |
| Ctrough of PF-07248144 |
Cycle 1 (Day 1), Cycle 1 (Day 15), Cycle 2 (Day 1), and Cycles 3, 5, and 7 (Day 1) only. Each Cycle is 28 days |
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Target Sample Size
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Total Sample Size="400"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
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15/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="5"
Months="3"
Days="0" |
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Recruitment Status of Trial (Global)
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Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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The purpose of this study is to learn about the safety and effects of the study medicine PF-07248144 when given along with fulvestrant for the possible treatment of HR-positive, HER2-negative advanced or metastatic breast cancer. HR-positive breast cancer cells have proteins on their surface called receptors that bind to hormones like estrogen and progesterone (female sex hormones). These hormones can promote the growth of cancer cells. HER2-negative describes cells that have a small amount or none of a protein called HER2 on their surface. In normal cells, HER2 helps control cell growth. Cancer cells that are HER2-negative may grow more slowly and are less likely to recur (come back) or spread to other parts of the body than cancer cells that have a large amount of HER2 on their surface. Advanced cancer is a term that is often used to describe cancer that is unlikely to be cured. Metastatic cancer is the type where the cancer cells spread from one part of the body to another. This study is seeking for participants whose breast cancer has gotten worsen after receiving cyclin dependent kinase (CDK) 4/6 inhibitor-based therapy. Half of participants in this study will receive their usual study treatment, everolimus with endocrine therapy (either exemestane or fulvestrant) for HR-positive/HER2-negative advanced or metastatic breast cancer (A/mBC). The study doctor will discuss which hormone therapy is right for the participant before treatment begins. PF-07248144 is a tablet that will be taken by mouth at home every day in a 28-day cycle. Fulvestrant will be given as two injections (one injection in the buttock) at visits to the study clinic. Everolimus and exemestane are also tablets and will be taken by mouth at home every day in a 28-day cycle. The study will compare the experiences of people receiving PF-07248144 in combination with fulvestrant to those of the people who do not. This will help see if PF-07248144 in combination with fulvestrant is safe and effective. |