Phase 4
Completed N=52
Safety Study of Pertuzumab (in Combination With Trastuzumab and Docetaxel) in Indian Participants With Breast Cancer
Source: ClinicalTrials.gov NCT02445586 ↗Enrolled (actual)
52
Serious AEs
59.6%
Results posted
Oct 2019
Primary outcomePrimary: Overall Number of Participants by the Number of Serious Adverse Events Reported Per Participant — 31; 17; 14; 21 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Number of Participants by the Number of Serious Adverse Events Reported Per Participant |
31; 17; 14; 21 | — |
| PRIMARY 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) |
1; 4; 15; 7; 14; 1 | — |
| PRIMARY Number of Participants With Serious Adverse Events Related to Docetaxel |
15; 5; 2; 2; 1; 1 | — |
| PRIMARY Number of Participants With Serious Adverse Events Related to Pertuzumab |
13; 4; 3; 2; 1; 1 | — |
| PRIMARY Number of Participants With Serious Adverse Events Related to Trastuzumab |
10; 3; 2; 2; 1; 1 | — |
| PRIMARY Overall Number of Participants With Serious Adverse Events by Action Taken With Study Drug |
0; 1; 1; 0; 3; 4 | — |
| PRIMARY Overall Number of Participants With Serious Adverse Events by Event Outcome |
15; 18; 1; 3; 2; 0 | — |
| PRIMARY Number of Participants With Hematological Abnormalities Reported as Serious Adverse Events |
2 | — |
| PRIMARY Number of Participants With Serum Chemistry Abnormalities Reported as Serious Adverse Events |
— | — |
| PRIMARY Number of Participants With Coagulation Abnormalities Reported as Serious Adverse Events |
1 | — |
| PRIMARY Number of Participants Who Died Due to a Serious Adverse Event by Cause of Death |
10; 1; 1; 1; 1; 1 | — |
| PRIMARY Overall Number of Participants by the Number of Non-Serious Adverse Events Reported Per Participant |
47; 11; 36; 5 | — |
| PRIMARY Overall Number of Participants With Non-Serious Adverse Events by Severity, According to NCI-CTCAE v4.03 |
38; 34; 12; 1; 0 | — |
| PRIMARY Number of Participants With Non-Serious Adverse Events Related to Docetaxel |
30; 12; 7; 6; 4; 4 | — |
| PRIMARY Number of Participants With Non-Serious Adverse Events Related to Pertuzumab |
20; 10; 5; 3; 3; 3 | — |
| PRIMARY Number of Participants With Non-Serious Adverse Events Related to Trastuzumab |
— | — |
| PRIMARY Overall Number of Participants With Non-Serious Adverse Events by Chemotherapy Adjustment With Docetaxel and/or Trastuzumab |
45; 9; 7 | — |
| PRIMARY Overall Number of Participants With Non-Serious Adverse Events by Action Taken With Pertuzumab |
47; 0; 0; 0 | — |
| PRIMARY Overall Number of Participants With Non-Serious Adverse Events by Event Outcome |
42; 12; 27; 2 | — |
| PRIMARY Overall Number of Participants With Non-Serious Adverse Events by Treatment Emergence (TEAE Versus Non-TEAE) |
47; 3 | — |
| PRIMARY Number of Participants With Hematological Abnormalities Reported as Non-Serious Adverse Events |
8; 4; 2; 1; 1; 1 | — |
| PRIMARY Number of Participants With Serum Chemistry Abnormalities Reported as Non-Serious Adverse Events |
4; 2; 1; 1; 1; 1 | — |
| PRIMARY Number of Participants With Coagulation Abnormalities Reported as Non-Serious Adverse Events |
1; 1; 1; 1; 1; 1 | — |
| PRIMARY Number of Participants With Congestive Heart Failure |
— | — |
| PRIMARY Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Over Time |
59.6; -0.7; -0.8; -0.2; 0.2; -0.8 | — |
| PRIMARY Number of Participants by Left Ventricular Ejection Fraction (LVEF) Findings Over Time |
50; 2; 0; 48; 3; 0 | — |
| PRIMARY Number of Participants With Adverse Events Leading to Treatment Discontinuation |
16; 5; 3; 2; 1; 1 | — |
| SECONDARY Overall Response Rate |
82.7; 17.3 | — |
| SECONDARY Number of Participants by Best Overall Response |
0; 43; 1; 6; 2 | — |
| SECONDARY Number of Participants With Disease Progression or Death or Who Were Censored for Progression-Free Survival Analysis |
32; 20 | — |
| SECONDARY Median Duration of Progression-Free Survival |
23.0 | — |
| SECONDARY Probability of Participants Remaining Event-Free in Progression-Free Survival From 2 to 32 Months |
98.08; 96.15; 90.27; 88.30; 82.42; 78.49 | — |
| SECONDARY Number of Participants Who Died or Were Censored for Overall Survival Analysis |
15; 37 | — |
| SECONDARY Median Duration of Overall Survival |
NA | — |
| SECONDARY Probability of Participants Remaining Alive in Overall Survival From 3 to 34 Months |
96.15; 88.30; 88.30; 88.30; 88.30; 83.66 | — |
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
Data sourced from ClinicalTrials.gov (NCT02445586). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.