Clinical trial NCT02445586: Safety Study of Pertuzumab (in Combination With Trastuzumab and Docetaxel) in Indian Participants With Breast Cancer
Official title: A Phase IV, Multicenter, Open-Label, Single-Arm Study of Pertuzumab (in Combination With Trastuzumab and Docetaxel) in First Line Treatment of Indian Patients With HER2-Positive Advanced (Metastatic or Locally Recurrent) Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-05-15
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 4, single-arm, open-label, multicenter study to assess the safety and efficacy of pertuzumab in combination with trastuzumab and docetaxel for the treatment of participants with human epidermal growth factor receptor 2 (HER2)-positive advanced (locally recurrent, unresectable, or metastatic) breast cancer.


Eligibility criteria: Inclusion Criteria:

* For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly-effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by the participant and/or partner
* Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection; participants with measurable and/or non-measurable disease are eligible
* Known and documented HER2-positive
* Known and documented LVEF of at least 50 percent (%)
* Adequate organ function
* A negative serum beta-human chorionic gonadotropin (beta-HCG) test for women of childbearing potential (premenopausal, or less than \[\<\] 12 months of amenorrhea post-menopause, and women who have not undergone surgical sterilization \[absence of ovaries and/or uterus\]) within 7 days prior to the first dose of study treatment with the result available prior to first dosing

Exclusion Criteria:

* Previous systemic non-hormonal anti-cancer therapy for the metastatic or locally recurrent disease
* Pregnant or lactating women
* Current clinical or radiographic evidence of central nervous system (CNS) metastases
* Disease progression while receiving or within 12 months of completion of trastuzumab and/or lapatinib treatment in the adjuvant or neo-adjuvant setting
* History of LVEF decline to below 50% during or after prior trastuzumab adjuvant or neo-adjuvant therapy

Primary outcomes:
measure: Overall Number of Participants by the Number of Serious Adverse Events Reported Per Participant
timeFrame: From Baseline until end of study (up to approximately 3 years)
measure: Overall Number of Participants With Serious Adverse Events by Severity (Initial and Most Extreme), According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03)
timeFrame: From Baseline until end of study (up to approximately 3 years)
measure: Number of Participants With Serious Adverse Events Related to Docetaxel
timeFrame: From Baseline until end of study (up to approximately 3 years)
measure: Number of Participants With Serious Adverse Events Related to Pertuzumab
timeFrame: From Baseline until end of study (up to approximately 3 years)
measure: Number of Participants With Serious Adverse Events Related to Trastuzumab
timeFrame: From Baseline until end of study (up to approximately 3 years)
measure: Overall Number of Participants With Serious Adverse Events by Action Taken With Study Drug
timeFrame: From Baseline until end of study (up to approximately 3 years)
measure: Overall Number of Participants With Serious Adverse Events by Event Outcome
timeFrame: From Baseline until end of study (up to approximately 3 years)
measure: Number of Participants With Hematological Abnormalities Reported as Serious Adverse Events
timeFrame: From Baseline until end of study (up to approximately 3 years)
measure: Number of Participants With Serum Chemistry Abnormalities Reported as Serious Adverse Events
timeFrame: From Baseline until end of study (up to approximately 3 years)
measure: Number of Participants With Coagulation Abnormalities Reported as Serious Adverse Events
timeFrame: From Baseline until end of study (up to approximately 3 years)
measure: Number of Participants Who Died Due to a Serious Adverse Event by Cause of Death
timeFrame: From Baseline until end of study (up to approximately 3 years)
measure: Overall Number of Participants by the Number of Non-Serious Adverse Events Reported Per Participant
timeFrame: From Baseline until end of study (up to approximately 3 years)
measure: Overall Number of Participants With Non-Serious Adverse Events by Severity, According to NCI-CTCAE v4.03
timeFrame: From Baseline until end of study (up to approximately 3 years)
measure: Number of Participants With Non-Serious Adverse Events Related to Docetaxel
timeFrame: From Baseline until end of study (up to approximately 3 years)
measure: Number of Participants With Non-Serious Adverse Events Related to Pertuzumab
timeFrame: From Baseline until end of study (up to approximately 3 years)
measure: Number of Participants With Non-Serious Adverse Events Related to Trastuzumab
timeFrame: From Baseline until end of study (up to approximately 3 years)
measure: Overall Number of Participants With Non-Serious Adverse Events by Chemotherapy Adjustment With Docetaxel and/or Trastuzumab
timeFrame: From Baseline until end of study (up to approximately 3 years)
measure: Overall Number of Participants With Non-Serious Adverse Events by Action Taken With Pertuzumab
timeFrame: From Baseline until end of study (up to approximately 3 years)
measure: Overall Number of Participants With Non-Serious Adverse Events by Event Outcome
timeFrame: From Baseline until end of study (up to approximately 3 years)
measure: Overall Number of Participants With Non-Serious Adverse Events by Treatment Emergence (TEAE Versus Non-TEAE)
timeFrame: From Baseline until end of study (up to approximately 3 years)
measure: Number of Participants With Hematological Abnormalities Reported as Non-Serious Adverse Events
timeFrame: From Baseline until end of study (up to approximately 3 years)
measure: Number of Participants With Serum Chemistry Abnormalities Reported as Non-Serious Adverse Events
timeFrame: From Baseline until end of study (up to approximately 3 years)
measure: Number of Participants With Coagulation Abnormalities Reported as Non-Serious Adverse Events
timeFrame: From Baseline until end of study (up to approximately 3 years)
measure: Number of Participants With Congestive Heart Failure
timeFrame: From Baseline until end of study (up to approximately 3 years)
measure: Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Over Time
timeFrame: Baseline, every 3 cycles (1 cycle is 21 days) until treatment discontinuation, at Safety Follow-Up (28 days after last dose of study drug) and every 3 months thereafter until end of study (up to approximately 3 years)
measure: Number of Participants by Left Ventricular Ejection Fraction (LVEF) Findings Over Time
timeFrame: Baseline, every 3 cycles (1 cycle is 21 days) until treatment discontinuation, at Safety Follow-Up (28 days after last dose of study drug) and every 3 months thereafter until end of study (up to approximately 3 years)
measure: Number of Participants With Adverse Events Leading to Treatment Discontinuation
timeFrame: From Baseline until end of study (up to approximately 3 years)
Secondary outcomes:
measure: Overall Response Rate
timeFrame: From Baseline up to disease progression or death (assessed at every 9 weeks, up to approximately 3 years)
measure: Number of Participants by Best Overall Response
timeFrame: From Baseline up to disease progression or death (assessed at every 9 weeks, up to approximately 3 years)
measure: Number of Participants With Disease Progression or Death or Who Were Censored for Progression-Free Survival Analysis
timeFrame: From Baseline up to disease progression or death (assessed at every 9 weeks, up to approximately 3 years)
measure: Median Duration of Progression-Free Survival
timeFrame: From Baseline up to disease progression or death (assessed at every 9 weeks, up to approximately 3 years)
measure: Probability of Participants Remaining Event-Free in Progression-Free Survival From 2 to 32 Months
timeFrame: Months 2, 3, 5, 6, 7, 8, 9, 11, 13, 15, 16, 17, 18, 19, 23, 24, 25, 27, 29, and 32
measure: Number of Participants Who Died or Were Censored for Overall Survival Analysis
timeFrame: From Baseline up to death from any cause (up to approximately 3 years)
measure: Median Duration of Overall Survival
timeFrame: From Baseline up to death from any cause (up to approximately 3 years)
measure: Probability of Participants Remaining Alive in Overall Survival From 3 to 34 Months
timeFrame: Months 3, 9, 13, 14, 15, 18, 19, 20, 24, 25, 27, 32, 33, and 34
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Institute & Research Center
state: Delhi
city: Mumbai
country: India
facility: Tata Memorial Hospital; Dept of Medical Oncology
state: Maharashtra
city: Mumbai
country: India
facility: Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
state: Maharashtra
city: Pune
country: India
facility: Jehangir Clinical Development Centre Pvt. Ltd; Cancer Research Room
state: Maharashtra
city: Vellore
country: India
facility: Christian Medical College & Hospital; Medicine
state: Tamil NADU
city: Hyderabad
country: India
facility: Indo-American Cancer Hospital & Research Center
state: Telangana
city: Kolkata
country: India
facility: TATA Medical Centre; Medical Oncology
state: WEST Bengal
city: Bangalore
country: India
facility: M S Ramaiah Memorial Hospital
city: Delhi
country: India
facility: MAX Balaji Hospital
Study officials:
affiliation: Roche Products (India) Pvt. Ltd.
name: Anil Kukreja, MD
role: STUDY_DIRECTOR
References: