| CTRI Number |
CTRI/2025/04/084336 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
04/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A Study to Learn About the Medicine Called PF-07220060 in Combination With Letrozole compared to CDK4/6i With Letrozole in People Over 18 Yr of Age With HR+ve, HER2-ve Advanced/Metastatic Breast Cancer who Have not Received any Prior Systemic Anticancer Treatment for Advanced/Metastatic Disease |
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Scientific Title of Study
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An Interventional, Open-Label, Randomized, Multicenter Phase 3 Study of PF-07220060 Plus Letrozole Compared to CDK4/6 Inhibitor Plus Letrozole in Participants Over 18 Years of Age With Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic Breast Cancer who Have not Received any Prior Systemic Anticancer Treatment for Advanced/Metastatic Disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
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| Secondary ID |
Identifier |
| 2024-512925-95-00 |
EudraCT |
| NCT06760637 |
ClinicalTrials.gov |
| Protocol No C4391024 Version-Original,dated 3-Sep-2024 |
Protocol Number |
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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
|
| Name |
Dr Seema Pai |
| Designation |
Sr 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 |
02266932000 |
| Fax |
|
| Email |
seema.pai@pfizer.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Pai |
| Designation |
Sr 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)
MAHARASHTRA
400051
India |
| Phone |
02266932000 |
| Fax |
|
| Email |
seema.pai@pfizer.com |
|
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Source of Monetary or Material Support
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| Pfizer Inc. 66 Hudson Boulevard East New York 10001 United States |
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Primary Sponsor
|
| Name |
Pfizer Inc |
| Address |
66 Hudson Boulevard East New York 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 400051, Maharashtra, India |
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Countries of Recruitment
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Argentina
Australia
Belgium
Brazil
Bulgaria
Canada
Chile
China
Czech Republic
Denmark
Finland
France
Germany
Greece
Hungary
India
Ireland
Israel
Italy
Japan
Mexico
Netherlands
Poland
Slovakia
Spain
Sweden
Switzerland
Taiwan
Turkey
United Kingdom
United States of America
Republic of Korea |
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Sites of Study
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| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shailesh Bondarde |
Apex Wellness Hospital |
Survey No. 799, plot no 187, Behind Prakash Petrol Pump, Govind nagar, Nashik 422009
Nashik
MAHARASHTRA |
9822012427
shaileshbondarde1971@gmail.com |
| Dr Sandip Ganguly |
Apollo Hospitals |
58, Canal Circular Road, Kolkata
700054
Kolkata
WEST BENGAL |
9903974739
dr.sandipganguly@gmail.com |
| Dr Priya Tiwari |
Artemis hospital |
Sector 51, Gurugram 122001
Gurgaon
HARYANA |
8377828241
Priya.Tiwari@artemishospitals.com |
| Dr Krishna Mohan MVT |
Basavatarakam Indo American Cancer Hospital and Research Institute |
Road No. 10, Banjara Hills, Hyderabad - 500034
Hyderabad
TELANGANA |
9866154503
mvtkm@yahoo.com |
| Dr Nirmal Raut |
Bhakti Vedanta Hospital and Research Institute |
Bhakti Vedanta Hospital and Research Institute, 3rd floor, Medical Research Department, Bhaktivedanta Swami Marg, Mira Road, Opposite to ISKCON temple, Thane 401107
Thane
MAHARASHTRA |
9930398156
pinirmal123@gmail.com |
| Dr Sachin Hingmere |
LMMFs, Deenanath Mangeshkar Hospital and Research Center |
off karve road, Erandawane
Pune
MAHARASHTRA |
9324517684
sshingmire@yahoo.com |
| Dr Anshul Agarwal |
Nirmal Hospital Pvt Ltd |
Department of Clinical Research, Ring Road, Surat 395002
Surat
GUJARAT |
91 9377113143
dranshulragarwal@gmail.com |
| Dr Dinesh Doval |
Rajiv Gandhi Cancer Institute and Research Centre |
Department of Oncology, Room No. 52, Sector V Rohini west Metro station Delhi, Southwest Delhi
New Delhi
DELHI |
911127051011
dcdoval@gmail.com |
| Dr Tushar Vishvasrao Patil |
Sahyadri Super Speciality Hospital |
30 C, Erandwane, Karve
Road, Pune 411004
Pune
MAHARASHTRA |
9552522556
tushar.patil@sahyadrihospitals.com |
| Dr Satheesh C T |
Spandana Oncology Centre |
#919, New No. 68, 28th main road, 9th block, Jayanagar, Bangalore 560069
Bangalore
KARNATAKA |
9242698750
drsatheeshct@gmail.com |
| Dr Sudeep Gupta |
Tata memorial Centre |
Tata Memorial Hospital, Homi Babha Building, Dr Ernest
Borges Rd, Parel East, Parel,
Mumbai 400012
Mumbai
MAHARASHTRA |
9821298642
sudeepgupta04@yahoo.com |
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Details of Ethics Committee
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| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Apex Wellness Ethics Committee, Apex wellness Hospital |
Approved |
| Artemis Health Science institutional Ethics Committee |
Approved |
| Bhaktivedanta Hospital Ethics Committee Bhaktivedanta Hospital and Research institute |
Approved |
| EC for Spandana Oncology Centre, Spandana Oncology Centre |
Approved |
| Institutional Ethics Committee Basavatarakam Indo American Cancer Hospital abd research Institute |
Approved |
| Institutional Ethics Committee, Apollo Multispeciality Hospitals Limited |
Approved |
| Institutional Ethics committee, Deenanath Mangeshkar Hospital and Research Centre |
Submittted/Under Review |
| Institutional Review Board, Rajiv Gandhi Cancer Institute and Research Centre |
Approved |
| NIRMAL HOSPITAL PVT. LTD ETHICS COMMITTEE |
Approved |
| Sahyadri Hospitals Pvt. Ltd., Ethics Committee, Sahyadri Clinical Research and Develeopment Center |
Approved |
| TMH Institutional Ethics Committee - I/ II, Tata Memorial Hospital |
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: C509||Malignant neoplasm of breast of unspecified site, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Arm A:
PF-07220060
Letrozole |
PF-07220060 tablet taken orally twice daily plus Letrozole tablet taken orally daily.
|
| Comparator Agent |
Arm B: Letrozole,
Abemaciclib,
Palbociclib,
Ribociclib |
Investigators Choice of CDK4/6 inhibitor (tablet/capsule) taken by mouth with letrozole tablet taken by mouth |
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
- Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.
- Documented estrogen receptor (ER) and/or progesterone receptor (PR)-positive tumor
- Documented HER2-negative tumor
- Previously untreated with any systemic anticancer therapy for their locally advanced or metastatic disease.
- Measurable disease or non-measurable bone only disease as defined by RECIST version 1.1 |
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| ExclusionCriteria |
| Details |
- In visceral crisis at risk of immediately life-threatening complications in the short term.
- Current or past history of central nervous system metastases.
- Have received prior (neo)adjuvant endocrine therapy (ET) and had recurrence during or within 12 months after the last dose of ET.
- Have received prior (neo)adjuvant CDK4/6i and had recurrence during or within 12 months after the last dose of CDK4/6i.
- Inadequate renal function, hepatic dysfunction, or hematologic abnormalities. |
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
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Centralized |
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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) by BICR: Time from the date of randomization to the date of the first documentation of objective progressive disease as determined by blinded independent central review (BICR) per RECIST v1.1, or death due to any cause, whichever occurs first |
Upto 13 years |
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Secondary Outcome
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| Outcome |
TimePoints |
| Overall Survival (OS): Time from the date of randomization to the date of death due to any cause |
Up to approximately 13 years |
| Progression Free Survival (PFS) by Investigator: Time from the date of randomization to the date of the first documentation of objective progressive disease as determined by investigator per RECIST v1.1, or death due to any cause, whichever occurs first |
Up to approximately 4 years |
OR by BICR & by investigator: Time from randomization date (every 8 weeks during the first 48 weeks & then every 12 weeks) to the date of progression OR death whichever occurs first
|
Up to approximately 4 years |
| Duration of Response (DoR) by BICR & by investigator: Time from the date of CR or PR to the first documentation of objective progressive disease, or death due to any cause, whichever occurs first |
Up to approximately 4 years |
| Incidence of treatment emergent treatment related adverse events (AE): Incidence & severity of AEs graded according to the NCI CTCAE v5.0 |
Up to 13 years. |
| Estimated mean change from baseline in EORTC QLQ C30 |
Up to approximately 4 years |
| Estimated mean change from baseline in BPI-SF |
Up to approximately 4 years |
| Estimated mean change from baseline in EQ-5D-5L |
Up to approximately 4 years |
| Estimated mean change from baseline in EORTC Breast Cancer Module (BR42) |
Up to approximately 4 years |
| Mean change from baseline of ctDNA |
Up to approximately 4 years |
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Target Sample Size
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Total Sample Size="1020"
Sample Size from India="30"
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)
|
05/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
06/01/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="13"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
The purpose of this study is to determine the safety and efficacy of PF-07220060 with letrozole compared to approved treatments (ie, palbociclib, ribociclib or abemaciclib with letrozole) in people with breast cancer: - HR-positive (breast cancer cells that need estrogen or progesterone to grow)
- HER2-negative (cells that have a small amount or none of a protein called HER2 on their surface);
- locally advanced (that has spread from where it started to nearby tissue or lymph nodes) or metastatic disease (the spread of cancer to other places in the body)
- who have not received any prior systemic anti-cancer treatment for advanced/metastatic disease.
Approximately half of the participants will receive PF-07220060 plus letrozole while the other half of participants will receive the investigator’s choice of treatment plus letrozole. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic. |