| CTRI Number |
CTRI/2023/02/050070 [Registered on: 24/02/2023] Trial Registered Prospectively |
| Last Modified On: |
20/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To Evaluate The Safety and Efficacy of Pertuzumab and Trastuzumab (Phesgo)in Breast Cancer Patients |
|
Scientific Title of Study
|
A PHASE IV, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS ADMINISTRATION OF THE FIXED-DOSE COMBINATION OF PERTUZUMAB AND TRASTUZUMAB (PHESGO) IN INDIAN PATIENTS WITH HER2-POSITIVE BREAST CANCER |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ML44030_Version 1_2Feb2022 |
Protocol Number |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
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| Affiliation |
|
| 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 Viraj Suvarna |
| Designation |
Medical Chapter Lead |
| 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
MAHARASHTRA
400 086
India
Mumbai
MAHARASHTRA
400 086
India |
| Phone |
9820006317 |
| Fax |
|
| Email |
viraj.suvarna@roche.com |
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Details of Contact Person
Public Query
Modification(s)
|
| Name |
Heta Khokhani |
| Designation |
Manager-Clinical Operations |
| 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
MAHARASHTRA
400 086
India
Mumbai
MAHARASHTRA
400 086
India |
| Phone |
9892440927 |
| Fax |
|
| Email |
heta.khokhani@roche.com |
|
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Source of Monetary or Material Support
|
| Roche Products India Pvt Ltd |
|
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Primary Sponsor
|
| Name |
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 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 13 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ajay Gogia |
All India Institute of Medical Sciences (AIIMS) |
Department of Medical Oncology, Dr.B.R.A, I.R.C.H, Ansari Nagar, New Delhi-110029, India
New Delhi
DELHI |
9013000642
ajaygogia@gmail.com |
| Dr Senthil Rajappa |
Basavatarakam Indo American Cancer Hospital & Research Institute |
Department of Medical Oncology, Road No 10, Banjara Hills, Hyderabad-500034
Hyderabad
TELANGANA |
9849213102
senthiljrajappa@gmail.com |
| Dr Suresh Advani |
Day Care Angels |
Advani Olickal Healthcare(AOH) ,3rd floor ,Sushrut Hospital and Research Centre, Oncology department,365,Swastik Park365, Swastik Park, Eastern Express Highway, Chembur East, Mumbai - 400071
Mumbai
MAHARASHTRA |
9821157706
shadvani2000@yahoo.com |
| Dr Chandragouda Dodagoudar |
Dr. B L Kapur Memorial Hospital |
Medical Oncology Department,
Pusa Rd, Radha Soami Satsang, Rajendra Place, New Delhi-110005
New Delhi
DELHI |
9958450124
drchandragouda.dodagoudar@blkhospital.com |
| Dr Naresh Somani |
HCG Cancer Centre |
HCG Cancer Centre
Shipra path 52/36, sector 5, Mansarovar, Jaipur-302020, Rajasthan, India
Jaipur
RAJASTHAN |
9116646910
drnaresh.s@hcgel.com |
| Dr Ashish Kaushal |
HCG-Cancer Centre |
Department of Medical Oncology, Sola Science City Road, Near Sola Bridge, S.G. Highway, Ahmedabad-380060, Gujarat, India
Ahmadabad
GUJARAT |
9978297842
drashish4@yahoo.co.in |
| Dr Satheesh CT |
Health Care Global Enterprises Ltd |
Medical Oncology Department, #8, HCG Towers, Tower-I, 2nd Floor, P.Kalinga Rao Road, Sampangiram Nagar, Bangalore-560027
Bangalore
KARNATAKA |
9242698750
drsatheeshct@gmail.com |
| Dr Chirag Desai |
Hemato Oncology Clinic Ahmedabad Pvt Ltd |
Hemato-Oncology Department, Opp. HDFC Bank, Beside Occura Eye Hospital & Pandit Deeyandayal Auditorium, Rajpath Club Road Lane, Off S. G. Highway, Ahmedabad 380054, Gujarat, lndia
Ahmadabad
GUJARAT |
9824047561
chiragdesai.oncology@gmail.com |
| Dr Poonam Patil |
Manipal Hospital |
Medical Oncology Department, 98, HAL Airport Road,Bangalore – 560017, Karnataka India
Bangalore
KARNATAKA |
8025024444
poonampatil@yahoo.com |
| Dr Meenu Walia |
Max Super Speciality Hospital |
Medical Oncology Department, Patparganj, 108-A, Indraprastha Extension, New Delhi-110092, India
New Delhi
DELHI |
9818994001
meenu.walia@maxhealthcare.com |
| Dr Ashok Vaid |
Medanta-The Medicity |
Medical oncology & Hematology Department, CH Bakhtawar Chowk, sector 38, Gurugram, Haryana-122001
Gurgaon
HARYANA |
0124-4141414
ashok.vaid@medanta.org |
| Dr Anand Pathak |
National Cancer Institute |
Medical Oncology Department, Khasara No. 25, Outer Hingna Ring Road, Mouza Jamtha, Nagpur-441 108,
Maharashtra, India.
Nagpur
MAHARASHTRA |
9823038498
abpathak21@gmail.com |
| Dr Rona Joseph P |
Regional Cancer Center |
Medical Oncology Department, Medical College Campus, Trivandrum, Kerala-695011
Thiruvananthapuram
KERALA |
8848634427
ronsjsph@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 13 |
| Name of Committee |
Approval Status |
| Dr. B.L. Kapur Memorial Hospital Ethics Committee |
Approved |
| Ethics Committee of CIMS, Hemato Oncology Clinic Ahmedabad Pvt Ltd |
Approved |
| Ethics Committee of Manipal Hospitals |
Approved |
| HCG Central Ethics Committee Health Care Global Enterprises Ltd |
Approved |
| HCG Multispecialty Ethics Committee, HCG Cancer Centre |
Approved |
| HCGEL Jaipur Institutional Ethics Committee |
Approved |
| Human Ethics Committee Regional Cancer Centre |
Approved |
| Institute Ethics Committee, AIIMS |
Approved |
| Institutional Ethics Committee Basavatarakam Indo American Cancer Hospital |
Approved |
| Institutional Ethics Committee, Max Super Speciality Hospital, |
Approved |
| Medanta Institutional Ethics Committee |
Approved |
| Mumbai Oncocare Centre IEC |
Approved |
| National Cancer Institute Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pertuzumab |
Pertuzumab IV is administered at a dose of 840 mg (loading dose) or 420 mg (maintenance dose) on Day 1 of each 3-week treatment cycle |
| Intervention |
Phesgo |
Phesgo SC is administered at a dose of 15 ml (loading dose) or 10 ml (maintenance dose) on Day 1 of each 3-week treatment cycle |
| Comparator Agent |
Trastuzumab |
Trastuzumab IV is administered at a dose of 8 mg/kg (loading dose) or 6 mg/kg (maintenance dose) on Day 1 of each 3-week treatment cycle |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Signed Informed Consent Form
Women of age ≥18 years at time of signing Informed Consent Form
HER2+ breast cancer status confirmed by local laboratory before study enrollment
Hormone receptor status of the primary tumor determined by local assessment |
|
| ExclusionCriteria |
| Details |
Treatment with investigational therapy within 4 weeks of enrollment
Serious cardiac illness or medical conditions
History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias
Inadequate bone marrow function |
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
1. Incidence and severity of adverse events (AEs), with severity determined according to the NCI CTCAE v5.0 grading scale.
a. Phesgo in combination with chemotherapy
b. Phesgo without concurrent chemotherapy
2. Incidence and severity of serious adverse events (SAEs), with severity determined according to the NCI CTCAE v5.0 grading scale
3. Incidence and severity of adverse events of special interest (AESIs) |
The primary analysis will be performed on safety analysis set that will include all enrolled patients who receive at least one dose of Phesgo or P plus H IV. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1 For Cohort 1 only: to evaluate total pathological complete response (tpCR)
2 For Cohort 3 only: to evaluate Overall Response Rate (ORR)
3 To assess healthcare professionals (HCP) perception on time/resource for using SC versus IV formulation |
At baseline and at end of the treatment period. |
|
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Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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 4 |
|
Date of First Enrollment (India)
|
01/03/2023 |
| 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="2"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
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Publication Details
|
Not applicable as of now |
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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
|
This is a Phase IV, open-label, randomized, crossover,
multicenter study designed to evaluate the safety and efficacy of Phesgo in
adult patients who have been diagnosed with HER2+ eBC or mBC in India.
All patients fulfilling the eligibility criteria and
willing to provide informed consent will be enrolled in the study. The estimated duration of patient enrollment
is approximately 20 months. The patient
enrollment will be stratified into three cohorts according to the breast cancer
stage and treatment setting. Cohort 1
will include patients diagnosed with HER2+ eBC and planning to take neoadjuvant
chemotherapy before surgery; Cohort 2 will include patients with
non-metastatic, adequately excised, histologically confirmed invasive HER2+ eBC
and planning to take adjuvant therapy; and Cohort 3 will include patients
diagnosed with HER2+ mBC who have not received prior anti-cancer therapy for
mBC. Patients will be enrolled into the
three cohorts in the ratio of 2:1:2 i.e., Cohort 1 (approximately 40% of total
enrolled population), Cohort 2 (approximately 20% of total enrolled population),
and Cohort 3 (approximately 40% of total enrolled population). Patients enrolled in Cohort 1 and completing
the neoadjuvant therapy would not be enrolled in Cohort 2.
Patient’s participation in the study will include three
periods: screening period, treatment period, and post-treatment period. Eligibility of the patients will be assessed
within a 28‑days screening period. |