CTRI

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CTRI Number

CTRI/2022/01/039625 [Registered on: 21/01/2022] Trial Registered Prospectively

Last Modified On:

14/10/2024

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Other

Public Title of Study

Phase-III STUDY TO DETERMINE SAFETY AND EFFICACY OF GIREDESTRANT COMPARED WITH PHYSICIANS CHOICE IN PATIENTS WITH ESTROGEN RECEPTOR POSITIVE, HER2 NEGATIVE EARLY BREAST CANCER

Scientific Title of Study

A PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF ADJUVANT GIREDESTRANT COMPARED WITH PHYSICIANS CHOICE OF ADJUVANT ENDOCRINE MONOTHERAPY IN PATIENTS WITH ESTROGEN RECEPTOR.POSITIVE, HER2-NEGATIVE EARLY BREAST CANCER

Trial Acronym

Secondary IDs if Any
Modification(s)

Secondary ID	Identifier
GO42784 Protocol Version 5.0 dated 25 Aug 2023	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Gopichand Mamillapalli
Designation	Chief Surgical Oncologist
Affiliation	HCG City Cancer Centre
Address	HCG City Cancer Centre, 33-25-33, CH. Venkata krishnayya Street, Suryarao Pet, Vijayawada Andhra Pradesh, India. Krishna ANDHRA PRADESH 520 002 India
Phone
Fax
Email	mgopichand@yahoo.com

Details of Contact Person
Scientific Query
Modification(s)

Name	Dr Viraj Suvarna
Designation	Medical Chapter Lead
Affiliation	Roche Products (India) Pvt. Ltd.
Address	146-B, 166 A, Unit No. 7, 8, 9 8th Floor, R City Office, R City Mall Lal Bahadur Shastri Marg Ghatkopar, Mumbai Mumbai MAHARASHTRA Mumbai MAHARASHTRA 400086 India
Phone	9820006317
Fax
Email	viraj.suvarna@roche.com

Details of Contact Person
Public Query
Modification(s)

Name	Amol Pawar
Designation	Manager -Clinical Operations
Affiliation	Roche Products (India) Pvt. Ltd.
Address	Roche Products (India) Pvt. Ltd. 146-B, 166 A, Unit No. 7, 8, 9 8th Floor, R City Office, R City Mall Lal Bahadur Shastri Marg Ghatkopar, Mumbai Mumbai MAHARASHTRA 400 086 India Mumbai MAHARASHTRA 400086 India
Phone	8080780992
Fax
Email	amol.pawar@roche.com

Source of Monetary or Material Support

Roche Products (India) Pvt. Ltd. 146-B, 166 A, Unit No. 7, 8, 9 8th Floor, R City Office, R City Mall Lal Bahadur Shastri Marg Ghatkopar, Mumbai - 400 086 Maharashtra ,India

Primary Sponsor

Name	F HoffmannLa Roche Ltd
Address	Grenzacherstrasse 124 CH 4070 Basel Switzerland
Type of Sponsor	Pharmaceutical industry-Global

Details of Secondary Sponsor

Name	Address
Roche Products India Pvt Ltd	146-B, 166 A, Unit No. 7, 8, 9 8th Floor, R City Office, R City Mall Lal Bahadur Shastri Marg Ghatkopar, Mumbai

Countries of Recruitment

Hong Kong
Hungary
Argentina
Australia
Austria
Belarus
Belgium
Bosnia and Herzegovina
Brazil
Bulgaria
Canada
Chile
China
Colombia
Costa Rica
Croatia
Czech Republic
Egypt
Finland
France
Georgia
Germany
Greece
Guatemala
India
Ireland
Israel
Jamaica
Japan
Kenya
Latvia
Malaysia
Mexico
Micronesia (Federated States of)
Netherlands
Peru
Philippines
Poland
Portugal
Republic of Korea
Romania
Russian Federation
Serbia
Slovakia
Slovenia
South Africa
Spain
Sweden
Switzerland
Taiwan
Thailand
Turkey
Uganda
Ukraine
United States of America
Viet Nam

Sites of Study
Modification(s)

No of Sites = 35
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Saroj Das Majumdar	All India Institute of Medical Sciences	Dept of Radiotherapy 298 Sijua Partrapada Bhubaneswar Odisha751019 India Bargarh ORISSA	9438884066 6742476789 sarojmajumdar@gmail.com
Dr Shailesh Bondarde	Apex Wellness Hospital	Clinical Research dept, Survey No. 799, Plot No. 187, Behind Prakash Petrol Pump, Govind Nagar, Nashik - 422009, Maharashtra, India Nashik MAHARASHTRA	9822012427 shaileshbondarde1971@gmail.com
Dr Mukul Goyal	ASIAN CANCER HOSPITAL	Room no 2 Basement Dept of Medical oncology B1 ASHADEEP ENCLAVE A NEAR AKSHYA PATRA JAGATPURA JAIPUR302025 Jaipur RAJASTHAN	9530370043 7073139602 drmukulgoyal@acricancer.in
Dr Jebasingh Joseph Dhanaraj	Asirvatham Speciality Hospital	Research Department 2nd floor OPD21 Rajaji Street Gandhinagar Madurai 625020 Tamil Nadu India Madurai TAMIL NADU	9442619775 452-2586353 jjebasingh@gmail.com
Dr Nagesh Shrinivasrao Madnoorkar	Chopda Medicare and Research Centre Pvt Ltd	Department of Oncology Ground Floor Chopda Medicare and Research Centre Pvt Ltd Magnum Heart Institute 3 5 Patil Lane No 1 Laxmi Nagar Near K.B.H. Vidyalaya Canada Corner Nashik 422005 Maharashtra India Nashik MAHARASHTRA	9822353986 2532316200 nageshmadnoorkar@gmail.com
Dr Divya Bala Thumaty	Christian Medical College	Department of Oncology Scudder Road Vellore 632004 Tamil Nadu India Vellore TAMIL NADU	9994383767 divyathumaty@cmcvellore.ac.in
Dr Kandappan Velavan	Erode Cancer Centre	OPD Ground Floor 1 393 Velavan Nagar perundurai road Thindal Erode 638 012 Erode TAMIL NADU	04242339704 04242339704 kvels@rediffmail.com
Dr Niti Raizda	Fortis Hospital Ltd	Dept. Of Medical & Hematooncology, Fortis Hospital Ltd, 154/9 Bannerghatta Road, Opp to IIM-B, Bangalore- 560076, Karnataka, India Bangalore KARNATAKA	9342991298 nitiraizada@yahoo.co.uk
Dr Ashok Kumar Diwan	Government Medical College and Hosptial Nagpur	Department of radiation oncology Room No 85 Medical Square Nagpur 440003 Maharashtra India Nagpur MAHARASHTRA	9822816608 7122743588 tinuad_07@hotmail.com
Dr Manasi Shah	HCG Cancer Centre	HCG OPD Tower 2nd Floor Science City Road Off S G Highway Ahmedabad 380060 Ahmadabad GUJARAT	7096012800 794041010 mansi1227@gmail.com
Dr Gopichand Mamillapalli	HCG City Cancer Centre	Department of Clinical research Consultation room no 1 CH Venkata krishnayya Street Suryarao Pet Vijayawada 520 002 Andhra Pradesh India Vizianagaram ANDHRA PRADESH	9885256059 8662436661 mgopichand@yahoo.com
Dr Rajnish Nagarkar	HCG Manavata Cancer Centre	Dep. Clinical Research HCG Manavata Cancer Centre, Behind Shivang Auto, Mumbai Naka, Nashik 422002, Nashik MAHARASHTRA	08662436661 9823061929 drraj@manavatacancercentre.com
Dr Ajay Omprakash Mehta	HCG NCHRI Cancer Centre	R No 1 ground floor Department of Surgical Oncology Khasra No 50 51 Mouja Wanjri Bande Nawaz Nagar Near Automotive Square Kalamna Ring Road Nagpur 440026 Maharashtra India Nagpur MAHARASHTRA	9823190192 9767347277 drmanjitrajput@gmail.com
Dr Bidisha Ghosh Naskar	Health Point Hospital	OPD building Room No 12 21 Prannath Pandit Street (Opp Lansdown Padmapukur) Kolkata700025 Kolkata WEST BENGAL	9432164842 6290554711 bghoshn@gmail.com
Dr chirag desai	Hemato Oncology Clinic Ahmedabad Pvt Ltd	Dept of Medical oncology. Hemato Oncology Clinic Ahmedabad Pvt Ltd, Opp. HDFC Bank, Beside Occura Eye Hospital and Pandit Deeyandayal Auditorium, Rajpath Club Road Lane, Off S.G.Highway, Ahmedabad- 380054, Gujarat, India Ahmadabad GUJARAT	7927906719 chiragdesai.oncology@gmail.com
Dr Rajesh Kumar Singh	Indira Gandhi Institute of Medical Sciences (IGIMS)	Department of Radiation Oncology Sheikhpura Patna 800 014 Bihar India Patna BIHAR	9939088899 6122297225 drrajeshrccigimstrial@gmail.com
Dr Koushik Chatterjee	Institute of Post Graduate Medical Education and Research	Department of Radiotherapy 244 AJC Bose Road Kolkata700020 West Bengal India Kolkata WEST BENGAL	9748457201 22235181 chatterjeedr.koushik@gmail.com
Dr Niraj Bhatt	Kailash Cancer Hospital and Research Center	Clinical Research Department 1st Floor Muniseva Ashram Goraj Waghodia Vadodara 391760 Vadodara GUJARAT	9925581480 2668268048 medonc12@gmail.com
Dr Anand Kumar Mishra	King Georgeâ€™s Medical University	Department of Endocrine Surgery King Georgeâ€™s Medical University Shahmina Road Chowk Lucknow 226003 Uttar Pradesh India Lucknow UTTAR PRADESH	9415007391 9415007391 mishra101@gmail.com
Dr SP Shrivastav	Kiran Hospital Multi Super Speciality Hospital and Research Center	Medical Oncology-Kiran Hospital Multi Super Speciality Hospital and Research Center, Near Sumul Dairy, Surat- 395004, Gujarat, India Surat GUJARAT	2617161111 communication@kiranhospital.com
Dr Rohan Bhise	KLES Dr Prabhakar Kore Hospital and Medical Research Centre	3rd Floor Department of Oncology Nehru Nagar Belgavi 590010 Karnataka India Belgaum KARNATAKA	9448866712 08312470732 rohanbhise30@gmail.com
Dr Nilesh Dhamne	Kolhapur Cancer Centre	Medical Oncology-Gokul Shirgaon, Karveer, A/p. R. S. No. 238, Kolhapur, 416 234, Maharashtra, India Kolhapur MAHARASHTRA	17738245698 dr.nilesh.gmc@gmail.com
Dr Prakash S Shivanna	Krishna Rajendra Hospital Mysore Medical College and Research Institute and Hospitals	Dept of Surgical Oncology 113 Mysuru Karnataka 580021 Mysore KARNATAKA	9901000559 8214232111 prakashyesyes@yahoo.com
Dr Ravikumar Wategaonkar	Lokmanya Holistic Cancer Care and Research Center of (LMRC)	3rd Floor 314 B Telco Road Chinchwad Pune 411033 Maharashtra lndia Pune MAHARASHTRA	9823602626 20-27456496 rnwategaonkar@gmail.com
Dr Nalini Kilara	M S Ramaiah Medical College and Hospitals	Department of Medical Oncology M S Ramaiah Nagar Msrit Post New Bel Road Bangalore 560054 Karnataka India Bangalore KARNATAKA	8040528400 8023601983 dranil.msr@gmail.com
Dr Ghanshyam Patel	Nirmal Hospital Pvt Ltd	Medical Oncology Nirmal Hospital Pvt Ltd, Ring Road, Surat- 395002, Gujarat, India Surat GUJARAT	6742540183 drgnpatelonco@gmail.com
Dr Shona Nag	Sahyadri Super Speciality Hospital	Oncology department 2nd floors 163 Bhosale Garden Road Aru Nagar Beside Bhosale Nagar Pune 411028 Maharashtra India Pune MAHARASHTRA	9371072441 2025459117 shonanag3@gmail.com
Dr Tushar Patil	Sahyadri Super Speciality Hospital	Dept of Medical oncology. 30 C Erandawane Road, Pune - 411004. Maharashtra, India Pune MAHARASHTRA	20254-03000 tussipats@hotmail.com
Dr Shriram Kane	Shalinitai Meghe Hospital And Research Centre	Medicine OPD 518 Ground Floor Wanadongri Hingna Nagpur 441110 Nagpur MAHARASHTRA	9823012851 shriramkane@gmail.com
Dr Rajesh Korant	Shree Himalaya Cancer Hospital And Research institute	Department of Clinical research Vinod Baug Railway Station No 4 Jetalpur Road Oipp Vadodara Sampatrao Colony Alkapuri Vadodara India Gujarat 390020 Vadodara GUJARAT	9725735728 drkorant.clinical@gmail.com
Dr Ghanashyam Biswas	Sparsh Hospital and Critical Care PLtd	Department of Clinical research A 407 Saheed Nagar Bhubaneshwar 751007 Odhisa India Balangir ORISSA	6742540183 6742545860 drgbiswas@gmail.com
Dr Rajendra Singh Arora	Sujan Surgical Cancer Hospital	Department of Clinical research 52 B Jail Road Shankar Nagar Main Road Amravati Maharashtra 444605 India Amravati MAHARASHTRA	9823097573 712671496 dr_rsarora@rediffmail.com
Dr Sudeep Gupta	Tata Memorial Hospital -Mumbai	Room No 1109 11th Floor Homi Bhabha Block Dr Ernest Borges Marg Parel Mumbai â€“ 400012 Maharashtra India Mumbai MAHARASHTRA	8217356417 2268735059 sudeepgupta@tatahospital.net
Dr Harsha Panchal	The Gujarat Cancer and Research Institute	R No 80 Old Building Clinical Trial Room M P Shah Cancer Hospital New Civil Hospital Campus Asarwa Ahmedabad 380016 Gujarat India Ahmadabad GUJARAT	7922688419 7922685490 harsha.panchal@gcriindia.org
Dr Nikhil Ghadyalpatil	Yashoda Hospitals	Room no 309 D Block Somajiguda Hyderabad500082 Telangana India Hyderabad TELANGANA	8600911911 4067776666 nikhilghadyalpatil@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 35
Name of Committee	Approval Status
ACH Ethics Committee ACH Ethics Committee	Submittted/Under Review
Amravati Ethics Committee Sujan Surgical Cancer Hospital And Research	Submittted/Under Review
APEX WELLNESS ETHICS COMMITTEE (AWEC)	Approved
BRIJ Independent Ethics Committee Independent Ethics committee Brij Psychiatry Hospital (IECBPH)	Approved
Ethics Committee MS Ramaiah Medical College and Hospital	Approved
Ethics Committee of CIMS (Care Institute of Medical Sciences)	Approved
Fortis Hospital Ethics Committee	Approved
GCRI/ GCS Ethics Committee	Approved
HCG Multi Specialty Ethics Commitee	Approved
HCG NCHRI Institutional Ethics Committee	Approved
Health Point Ethics Committee	Submittted/Under Review
Institutional Ethics Committe-AlIMS	Submittted/Under Review
Institutional ethics committee	Approved
Institutional Ethics Committee I	Submittted/Under Review
Institutional Ethics Committee Mysore Medical College and Research Institute and Attached Hospitals	Submittted/Under Review
Institutional Ethics committee Asirvatham Speciality Hospital	Submittted/Under Review
Institutional Ethics Committee Department of Pharmacology Government Medical College and Hospital Medical Square	Submittted/Under Review
Institutional Ethics Committee HCG Curie City Cancer Centre	Approved
Institutional Ethics Committee IGIMS	Approved
Institutional Ethics Committee King Georgeâ€™s Medical University	Approved
Institutional Ethics Committee KLE	Approved
Institutional Ethics Committee Sparsh Hospital	Approved
Institutional Ethics Committee Yashoda Hospital	Submittted/Under Review
Institutional Review Board(Ethics Committee Silver)	Submittted/Under Review
IPGME AND R Research Oversight Committee	Approved
Jasleen Hospitals Ethics Committee	Approved
Kailash Cancer and Medical Centre-Institutional Ethics Committee	Approved
Kiran Hospital Ethics Committee	Approved
Kolhapur Cancer Centre Institutional Ethics Committee	Approved
Lokmanya Medical Research Centre	Submittted/Under Review
Magna Care Ethics Committee	Approved
Manavata Clinical Research Ethics Committee	Approved
Nirmal Hospital Pvt Ltd Ethics Committee	Approved
Sahyadri Hospitals PVt LTD Ethics Committee Sahyadri Clinical Research and Development Center-Erandawane	Approved
Sahyadri Hospitals PVt LTD Ethics Committee -Hadapsar	Submittted/Under Review

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: C50\|\|Malignant neoplasm of breast,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Control Arm TPC limited to either tamoxifen or one of the specified third-generation AIs b: anastrozole, letrozole, or exemestane	Tamoxifen, Anastrozole, Letrozole, Exemestane will be administered Orally and Dose and Frequency is as per the local Prescribing information The duration of the treatment is Adjuvant Treatment Phase (for 5 years)
Intervention	Experimental Arm Giredestrant b 30 mg once a day	Giredestrant will be administered Orally with dose of 30 mg once a day Adjuvant Treatment Phase (for 5 years)

Inclusion Criteria

Age From	18.00 Year(s)
Age To	75.00 Year(s)
Gender	Both
Details	Participants who are capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the Informed Consent Form and in this protocol - Participants (females, regardless of menopausal status, and males) who are age 18 years at the time of signing the Informed Consent Form - Participants who have documented ERï€« tumor by immunohistochemistry, as assessed locally on a primary disease specimen and defined as ï‚³ 1% of tumor cells stained positive according to the ASCO/College of American Pathologists (CAP) guidelines (Allison et al. 2020). - Participants who have documented HER2ï€ tumor, as assessed locally on a primary disease specimen and defined according to ASCO/CAP guidelines (Wolff et al. 2018) Participants who have multicentric (the presence of two of more tumor foci within different quadrants of the same breast) and/or multifocal (the presence of two or more tumor foci within a single quadrant of the breast) breast cancer are also eligible if all examined tumors meet pathologic criteria for ER positivity and HER2 negativity â€“ Participants with bilateral synchronous invasive breast cancer are eligible if all histopathologically examined tumors meet pathologic criteria for ER positivity and HER2 negativity. - Participants must have undergone definitive surgery of the primary breast tumor(s). With the exception of the situations described below, the margins of the resected specimen must be histologically free of invasive tumor and/or a component of ductal carcinoma in situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the participant must undergo mastectomy to be eligible. Of note, participants with margins positive for lobular carcinoma in situ (LCIS) are eligible without additional resection. For participants who undergo mastectomy or wide local excision where deep margin abuts the pectoralis fascia, participants with microscopic positive margins are eligible as long as radiotherapy of the chest wall is administered prior to study entry. Participants with positive anterior margins may be eligible if there is no gross disease left behind (radiotherapy as per local guidelines). â€“ Participants with suspected metastasis in supraclavicular or internal mammary nodes should be treated in accordance with standard local guidelines. â€“ If given, radiation therapy (e.g., post-mastectomy or post-lumpectomy) should be administered according to standard guidelines. - Participants who received or will be receiving adjuvant chemotherapy must have completed adjuvant chemotherapy prior to randomization. Participants may also have received neoadjuvant chemotherapy. A washout period of at least 21 days is required between last adjuvant chemotherapy dose and randomization. â€“ Participants who are not candidates for adjuvant chemotherapy or decline chemotherapy are permitted. - Participants for whom resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE v5.0 Grade 1 or better (except alopecia, Grade ï‚£ 2 peripheral neuropathy, arthralgia, or other toxicities not considered a safety risk for the participant per the investigatorâ€™s judgment) - Participants have received (neo)adjuvant chemotherapy and/or had surgery and had no prior endocrine therapy are eligible, provided that they are enrolled within 12 months following definitive breast cancer surgery - Participant who have Eastern Cooperative Oncology Group Performance (ECOG) Performance Status 0, 1, or 2 etc...

ExclusionCriteria

Details

- Participants who are pregnant or breastfeeding, or intending to become pregnant
during the study or within 9 days after the final dose of giredestrant, or within the
time period specified per local prescribing guidelines after the final dose of TPC.
- Participants who have been diagnosed with Stage IV breast cancer
- Participants who have a history of any prior (ipsilateral and/or contralateral) invasive
breast cancer or DCIS. Participants with a history of contralateral DCIS treated by
only local regional therapy at any time may be eligible.
- Participants who have a history of any other malignancy within 3 years prior to
screening, except for appropriately treated carcinoma in situ of the cervix,
non-melanoma skin carcinoma, or Stage I uterine cancer.
Women of childbearing potential must have a negative serum pregnancy test
result within 7 days prior to initiation of study treatment and a negative urine
pregnancy test within 24 hours prior to study treatment initiation.
- Participants who have received treatment with investigational therapy within 28 days
prior to initiation of study treatment or is currently enrolled in any other type of
medical research judged by the Sponsor not to be scientifically or medically
compatible with this study
- Participants receiving or planning to receive a CDK4/6i as adjuvant therapy
- Participants who have active cardiac disease or history of cardiac dysfunction,
- Participants who have had any prior endocrine treatment with selective ERdownregulators, degraders, or AI

Method of Generating Random Sequence

Stratified randomization

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To demonstrate superiority of giredestrant over the control treatment.	Baseline , every 3 cycle(as clinically indicated)

Secondary Outcome

Outcome	TimePoints
To evaluate health status utility scores of participants treated with giredestrant compared with TPC	baseline, Cycle 3, Cycle 6, Cycle 9 there after every 3 cycles

Target Sample Size

Total Sample Size="4700"
Sample Size from India="245"
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)

27/01/2022

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

07/07/2021

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="10"
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

Not yet

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

This is a Phase III, global, randomized, open-label, multicenter study evaluating the efficacy and safety of adjuvant giredestrant compared with TPC in participants with medium- and high-risk Stage Iï€III histologically confirmed ER+ and HER2 -EBC. Participants will be treated daily with giredestrant or TPC for at least 5 years. During the study, participants will be regularly assessed for efficacy, safety, and health-related quality of life. Participants who complete the 5-year study treatment will enter long-term follow-up for at least 5 years.

Approximately 4700 participants will be screened to achieve random assignment in 1:1 ratio to study treatment of 4100 randomized participants for an estimated total of 2050 randomized participants per treatment group

The total duration of study participation for each individual is expected to be approximately 10 years (5 years of treatment followed by 5 years of follow-up).