| CTRI Number |
CTRI/2024/07/069956 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment |
|
Scientific Title of Study
|
An Interventional, Open-label, randomized, multicentre Phase
3 study of PF-07220060 plus fulvestrant compared to investigators
choice of therapy in participants over 18 years of age with hormone receptor-positive, HER2-Negative advanced/metastatic breast cancer whose disease progressed after prior CDK 4/6 inhibitor based therapy.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2023-506487-13-00 |
EudraCT |
| NCT06105632 |
ClinicalTrials.gov |
| Protocol C4391022 (Final Protocol, 30 June 2023) |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Pai |
| Designation |
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-400051,MAHARASHTRA, India
Mumbai
MAHARASHTRA
400051
India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02266932000 |
| Fax |
|
| Email |
Seema.Pai@pfizer.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Pai |
| Designation |
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-400051,MAHARASHTRA, India
Mumbai
MAHARASHTRA
400051
India
MAHARASHTRA
400051
India |
| Phone |
02266932000 |
| Fax |
|
| Email |
Seema.Pai@pfizer.com |
|
|
Source of Monetary or Material Support
|
| Pfizer Inc. 66 Hudson Boulevard East New York, NY 10001 |
|
|
Primary Sponsor
|
| Name |
Pfizer Inc. |
| Address |
66 Hudson Boulevard East New York, NY 10001 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Pfizer Limited |
The Capital, 1802/1901, Plot No. C-70 G Block, Bandra Kurla Complex, Bandra (E), Mumbai City (India) - 400051 |
|
|
Countries of Recruitment
|
Argentina
Australia
Belgium
Brazil
Bulgaria
Canada
China
Czech Republic
Denmark
Finland
France
Germany
Greece
Hungary
India
Israel
Italy
Japan
Mexico
Poland
Republic of Korea
Slovakia
Spain
Sweden
Taiwan
Turkey
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shailesh Bondarde |
Apex Wellness Hospital |
Clinical Research Department Old Canal Link Road, Nashik-422009, Maharashtra, India
Nashik
MAHARASHTRA |
9822012427
shaileshbondarde1971@gmail.com |
| Dr Sandip Ganguly |
Apollo Multispeciality Hospitals Limited |
58, Canal Circular Road, Main building , Mezzanine floor, Kadapara, Kolkata, 700054
Kolkata
WEST BENGAL |
919663667459
dr.sandipganguly@gmail.com |
| Dr Nirmal Raut |
Bhakti Vedanta Hospital & Research Institute |
Srishti Complex, Bhaktivedanta Swami Marg, Mira Road East, Thane 401107
Thane
MAHARASHTRA |
9930398156
pinirmal123@gmail.com |
| Dr Rohit Dominic Jawahar Rebello |
GBH Memorial Cancer Hospital |
Near Transport Nagar, Airport Road Bedwas, Bedwas Rural, Udaipur-313002, Rajasthan, India.
Udaipur
RAJASTHAN |
7984315265
dr.rohitresearch@gmail.com |
| Dr Saurabh Rajeshwar Prasad |
KIMS Kingsway Hospitals |
44, Parwana Bhawan,
Near Kasturchand Park, Kingsway, Nagpur 440001, Maharashtra, India.
Nagpur
MAHARASHTRA |
7066580511
drsaurabhprasad@gmail.com |
| Dr Anshul Agarwal |
Kiran Hospital - Multi Super Speciality Hospital and Research Center |
Clinical Research Department 2nd floor Near Sumul Dairy, Surat 395004, Gujarat, India
Surat
GUJARAT |
9377113143
dranshulragarwal@gmail.com |
| Dr Dinesh Doval |
Rajiv Gandhi Cancer Institute and Research Centre |
Department of Medical Oncology, Room no 52 Sector 5, Rohini, New Delhi, 110085, Delhi, India.
New Delhi
DELHI |
911127051011
dcdoval@gmail.com |
| Dr Tushar Vishvasrao Patil |
Sahyadri Super Speciality Hospital |
30C, Erandwane, Karve Road Pune 411004
Pune
MAHARASHTRA |
9552522556
tussipats@hotmail.com |
| Dr CT Satheesh |
Spandana Oncology Centre |
919, New No 68, 28th Main Road, 9th Block Jayanagar, Bangalore 560068
Bangalore
KARNATAKA |
9242698750
drsatheeshct@gmail.com |
| Dr Sudeep Gupta |
Tata Memorial Hospital |
Dr. Ernest Borges Marg,
Parel East, Mumbai 400012
Mumbai
MAHARASHTRA |
91-22-24177000
sudeepgupta04@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Apex Wellness Ethics Committee - AWEC Apex Wellness Hospital |
Approved |
| Bhaktivedanta Hospital Ethics Committee |
Approved |
| Ethics Committee GBH Memorial Cancer Hospital |
Approved |
| IEC for Spandana Oncology Centre |
Approved |
| Institutional Ethics Committee (IEC)-I |
Approved |
| Institutional Ethics Committee Apollo Multispeciality Hospitals Limited |
Approved |
| Institutional Review Board Rajiv Gandhi Cancer Institute and Research Centre |
Approved |
| Kingsway Hospitals Ethics Committee |
Approved |
| Kiran Hospital Ethics Committee Kiran Hospital |
Approved |
| Sahyadri Hospitals Pvt Ltd Ethics Committee |
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 |
Everolimus |
Everolimus Tablets, orally, once daily, continuously in a 28-day cycle |
| Comparator Agent |
Exemestane |
Exemestane Tablets, orally, once daily, continuously in a 28-day cycle |
| Intervention |
Fulvestrant |
Arm A: Fulvestrant,
intramuscularly on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle starting from C2D1 (28- day cycle).
Arm B: Fulvestrant 500 mg, intramuscularly on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle starting from C2D1 (28- day cycle), |
| Intervention |
PF-07220060 CDK4 inhibitor |
Arm A: Participants will receive PF-07220060 as three 100 mg tablets, orally, twice daily, continuously in a 28-day
cycle, |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 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
- Able to provide a sufficient amount of representative formalin fixed, paraffin embedded (FFPE) tumor tissue specimen.
- Must have received CDK4/6i plus NSAI defined per study protocol. There must be documented PD during or after CDK4/6i treatment.
- Measurable disease or non-measurable bone only disease as defined by RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) less than equal to 2. |
|
| ExclusionCriteria |
| Details |
- Any medical or psychiatric condition that may increase the risk of study participation or make the participant inappropriate for the study.
- In visceral crisis at risk of immediately life-threatening complications in the short term.
- Known active uncontrolled or symptomatic central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.
- Prior treatment with any of the following:
- Everolimus or investigational anti-cancer agents in any setting
- Prior chemotherapy in the advanced setting
- Radiation within 2 weeks of randomization
- Current use or anticipated need for any prohibited food, supplements or concomitant medication(s) (ie, other anti-cancer therapies, other endocrine therapies, growth factors, chronic systemic corticosteroids, strong cytochrome P450 3A4/5 [CYP3A4/5] or uridine 5 diphosphate-glucuronosyltransferase 2B7 [UGT2B7] inhibitors and inducers, direct oral anticoagulants, proton pump inhibitors).
- Inadequate renal function, hepatic dysfunction, or hematologic abnormalities. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
(1) Progression-Free Survival (PFS) progression, as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
(2) Number of Participants with Objective Response (OR) |
(1) From Initiation up to 2 years
(2) Baseline up to 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall Survival (OS) |
Time from the date of randomization to the date of death due to any cause up to approximately 5 years |
| PFS as defined by investigator |
Time from the date of randomization up to approximately 2 years |
| OR by BICR & by investigator per RECIST v1.1 |
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 2 years) |
| Duration of Response (DOR) as define by Blinded Independent Central Review (BICR) & by investigator per RECIST v1.1 |
From the date of the first objective response (every 8 weeks during the first 48 weeks & then every 12 week) up to approximately 2 years. |
| Number of Participants With Clinical Benefit Response (CBR) by BICR & by investigator per RECIST v1.1 |
From randomization date (every 8 weeks during the first 48 weeks & 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 3 years |
| Number or Patients with AEs by Incidence |
From screening until 28 days after the last dose, to approximately 3 years |
| Number or Patients with AEs by Seriousness |
From screening until 28 days after the last dose, to approximately 3 years |
| Number or Patients with AEs by relationship to study interventions |
From screening until 28 days after the last dose, to approximately 3 years |
| Number of Participants With Abnormal Electrocardiogram (ECG) |
From baseline to approximately 2 years |
| Number of Participants With Laboratory Test Abnormalities |
From screening until 28 days after the last dose to approximately 2 years |
| EQ-5D-5L |
Screening Days 1, 15 of Cycle 1 & 2, Day 1 of Cycles 3-6, then Day 1 of every other subsequent Cycle starting with Cycle 8 (eg, Cycles 8, 10, 12, etc), EoT & Safety FU until 28 days after the last dose to approximately 2 years. Each Cycle is 28 days |
| EORTC QLQ |
Screening Days 1, 15 of Cycle 1 & 2, Day 1 of Cycles 3-6, then Day 1 of every other subsequent Cycle starting with Cycle 8 (eg, Cycles 8, 10, 12, etc), EoT & Safety FU until 28 days after the last dose to approximately 2 years. Each Cycle is 28 days |
| EORTC QLQ Breast Cancer Module 23 (BR23) |
Screening Days 1, 15 of Cycle 1 & 2, Day 1 of Cycles 3-6, then Day 1 of every other subsequent Cycle starting with Cycle 8 (eg, Cycles 8, 10, 12, etc), EoT & Safety FU until 28 days after the last dose to approximately 2 years. Each Cycle is 28 days |
| Ctrough of PF-07220060 |
Cycle 1 (Day 15), Cycle 2 (Day 1), & Cycle 3 (Day 1). Each Cycle is 28 days |
|
|
Target Sample Size
|
Total Sample Size="510"
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" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
19/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/12/2023 |
| 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)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
The purpose of this study is to learn about the safety and how effective the study medicine (PF-07220060) plus fulvestrant is compared to the study doctor’s choice of treatment in people with advanced or metastatic breast cancer. Advanced cancer is the one that is unlikely to be cured or taken care of with treatment. Metastatic cancer is the one that has spread to other parts of the body. This study is seeking female and male participants who: - are 18 years of age or older;
- are hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative;
- have advanced or metastatic breast cancer after taking other treatments before this study;
- have not taken or need to take medications that are not allowed by the study protocol;
- do not have any medical or mental conditions that may increase the risk of study participation.
Half of the participants will take PF-07220060 two times daily by mouth along with fulvestrant. Fulvestrant will be given as a shot into the muscle. The other half will take the study doctor’s choice of treatment which can either be: - Fulvestrant alone taken as shot into the muscle.
- Everolimus along with exemestane taken once daily by mouth.
This study will compare the experiences of participants receiving the study medicine plus fulvestrant to those who are receiving the study doctor’s choice of treatment. This will help decide if the study medicine is safe and effective. Participants will receive study treatment and/or will be in the study until: - imaging scans (such as an MRI and/or CT) show that their cancer is getting worse.
- the study doctor thinks the participant is no longer benefitting from the study medicine.
- has side effects that become too severe. A side effect is a reaction (expected or unexpected) to a medicine or treatment you take.
- the participant chooses to stop taking part.
|