Description:
To verify that combination therapy with trastuzumab + pertuzumab + eribulin brings similar
PFS and better QOL compared to trastuzumab + pertuzumab + taxane in advanced/recurrent
HER2-positive breast cancer patients who have no medical history of chemotherapy except
ado-trastuzumab emtansine
Title
- Brief Title: A Study to Compare Eribulin Mesylate + Pertuzumab + Trastuzumab With Paclitaxel or Docetaxel + Pertuzumab + Trastuzumab
- Official Title: A Phase III Clinical Study to Compare the Combination Therapy of Eribulin Mesylate + Pertuzumab + Trastuzumab With Paclitaxel or Docetaxel + Pertuzumab + Trastuzumab (EMERALD)
Clinical Trial IDs
- ORG STUDY ID:
JBCRG-M06
- NCT ID:
NCT03264547
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Pertuzumab | Perjeta | Arm A |
Trastuzumab | Herceptin | Arm A |
Docetaxel | Taxotere | Arm A |
Paclitaxel | Taxol | Arm A |
Eribulin | Halaven | Arm B |
Purpose
To verify that combination therapy with trastuzumab + pertuzumab + eribulin brings similar
PFS and better QOL compared to trastuzumab + pertuzumab + taxane in advanced/recurrent
HER2-positive breast cancer patients who have no medical history of chemotherapy except
ado-trastuzumab emtansine
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A | Active Comparator | Trastuzumab + pertuzumab + Taxane*
*Taxane is chosen from the following; Docetaxel or Paclitaxel | - Pertuzumab
- Trastuzumab
- Docetaxel
- Paclitaxel
|
Arm B | Experimental | Trastuzumab+ Pertuzumab + Eribulin | - Pertuzumab
- Trastuzumab
- Eribulin
|
Eligibility Criteria
Inclusion Criteria:
1. Patients with breast cancer that is confirmed histologically or cytologically
2. Patients who are confirmed to be HER2 positive for the primary or a metastatic lesion
at a participating medical institution
3. Patients with no medical history of treatment for advanced/recurrent cancer using a
regimen of drugs including chemotherapeutics
4. >=6 months have passed since perioperative treatment with anticancer agents
5. Presence of a measurable lesion not required
6. Female aged 20-70 years old at the time of consent acquisition
7. Baseline left ventricular ejection fraction (LVEF) measured by ECHO or MUGA of >=50%
8. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1
9. Patients who have maintained major organ functions, meeting all of the following
criteria on a test within 28 days before enrollment. If there are multiple test
results during this period, that obtained immediately before enrollment should be
adopted.
(1) Neutrophil count: >=1,500/mm3 (2) Platelet count: >=100,000/mm 3 (3) Hemoglobin: >=9.0
g/dL (4) Total bilirubin: <=1.5 mg/dL (5) AST (GOT), ALT (GPT): <=2.5 times the ULN (<=5
times in those with liver metastasis) (6) Serum creatinine: <=1.5 mg/dL 10) Patients with a
life expectancy of at least 6 months 11) Patient who submits written consent herself after
receiving sufficient explanation about this study 12) Patients who can undergo QOL
investigation
Exclusion Criteria:
1. Patients planning to undergo radical surgery if they respond to a treatment
2. Patients who have non-hematological adverse events assessed as Grade >=3 in the Common
Terminology Criteria for Adverse Events ver. 4.0 in the Japanese JCOG version (CTCAE
v4.0-JCOG) at the time of enrollment
3. Patients who have symptomatic metastases to the central nervous system or whose
symptoms are hard to control
4. Patients who have active double cancer
5. Patients who have poorly controlled hypertension, or unstable angina
6. Patients who have a past history of congestive heart failure assessed as Class ll or
higher in the New York Heart Association (NYHA) classification, or clinically
significant arrhythmia requiring treatment
7. Patients with a past history of myocardial infarction within 6 months before
enrollment
8. Patients who are expected to undergo major surgical treatment or who had severe injury
within 28 days before enrollment, or who require major surgical treatment during the
study treatment period
9. Patients with interstitial pneumonia which is symptomatic or requires treatment
10. Pregnant women, those with a positive pregnancy test, and lactating women
11. Patients with active systemic infection (including HCV and HBV), or who are found to
be HIV-positive
12. Patients with hypersensitivity against pertuzumab and trastuzumab
13. Patients whom the investigator consider unable or unwilling to follow the protocol
requirements
Maximum Eligible Age: | 70 Years |
Minimum Eligible Age: | 20 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | PFS |
Time Frame: | 5.75 years |
Safety Issue: | |
Description: | Progression-free survival |
Secondary Outcome Measures
Measure: | RR |
Time Frame: | 5.75 years |
Safety Issue: | |
Description: | Response rate |
Measure: | DR |
Time Frame: | 5.75 years |
Safety Issue: | |
Description: | Duration of response |
Measure: | OS |
Time Frame: | 6.25 years |
Safety Issue: | |
Description: | Overall survival |
Measure: | PRO |
Time Frame: | 5.75 years |
Safety Issue: | |
Description: | Patient-reported outcomes(Numbness & tingling) |
Measure: | Safety |
Time Frame: | 5.75 years |
Safety Issue: | |
Description: | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] |
Measure: | Biomaker |
Time Frame: | 5.75 years |
Safety Issue: | |
Description: | DNA mutation in the ctDNA and tumor tissue such as HER2,HER3, and PIK3CA |
Measure: | nMFS |
Time Frame: | 5.75 years |
Safety Issue: | |
Description: | new Metastases free survival |
Measure: | TTF of the subsequent treatment |
Time Frame: | 5.75 years |
Safety Issue: | |
Description: | Treatment duration of the following treatment |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Japan Breast Cancer Research Group |
Last Updated
September 21, 2017