Clinical trial NCT02419742: Safety and Efficacy of Trastuzumab as Part of Breast Cancer Treatment Regimen
Official title: An Indian Multicentric Open Label Prospective Phase IV Study to Evaluate Safety and Efficacy of Trastuzumab in Her2 Positive, Node Positive or High Risk Node Negative Breast Cancer as Part of a Treatment Regimen Consisting of Doxorubicin, Cyclophosphamide, With Either Docetaxel or Paclitaxel (AC-TH) or Docetaxel and Carboplatin (TCH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-04-17
Enrollment: 110
Sex: FEMALE
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 prospective, Phase IV, multi-center, single arm, open-label, interventional study to evaluate the safety of trastuzumab for the treatment of human epidermal growth factor receptor 2 protein (HER2)-positive node positive or high risk node negative breast cancer participants with regimen consisting of doxorubicin and cyclophosphamide followed by either paclitaxel or docetaxel (AC-TH Regimen) or a regimen consisting of docetaxel and carboplatin (TCH Regimen) in Indian population.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed early invasive HER2 positive, node positive or high risk node negative breast cancer with no evidence of residual, locally recurrent or metastatic disease and defined as clinical stage I to IIIA that is eligible for adjuvant treatment with trastuzumab
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* HER2 over expression/amplification defined as either Immunohistochemistry (IHC)3+, or IHC2+ and Fluorescence in situ Hybridization (FISH) positive as determined in a central laboratory
* At time of starting trastuzumab therapy, LVEF measured by echocardiography
* Screening LVEF greater than or equal to (\>/=) 55 percent (%)
* Adequate bone marrow, renal, and hepatic function
* Agreement to use an adequate, non-hormonal means of contraception by women of childbearing potential

Exclusion Criteria:

* Any contraindication to trastuzumab
* Previous adjuvant breast cancer treatment with an approved or investigational anti-HER2 agent
* History of other malignancy, except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma and participants with other curatively treated malignancies who have been disease-free for at least 5 years
* Past history of ductal carcinoma in situ and/or lobular carcinoma that has been treated with any systemic therapy or with radiation therapy to the ipsilateral breast where the invasive cancer subsequently develops
* Locally advanced (Stage IIIB and IIIC) and metastatic disease (Stage IV)
* Clinically relevant cardiovascular disorder or disease
* Uncontrolled hypertension, or history of hypertensive crisis or hypertensive encephalopathy
* History of severe allergic or immunological reactions, example difficult to control asthma
* Pregnant or lactating women

Primary outcomes:
measure: Clinically Significant Changes in Cardiac Function As Determined by Left Ventricular Ejection Fraction (LVEF) Measurements Using Echocardiography
timeFrame: Baseline to every 4 cycles up to Cycle 21 (AC-TH), every 4 cycles up to Cycle 17 (TCH) (each cycle is 21 days), at study treatment completion (12 months post baseline) at 6 month (18 months post baseline) and 12 month follow-up (24 months post baseline)
measure: Percentage of Participants With Adverse Events
timeFrame: Baseline up to approximately 5 years and 10 months
Secondary outcomes:
measure: Disease Free Survival (DFS)
timeFrame: The date of first study treatment to the date of local, regional or distant recurrence, contra-lateral breast cancer or death due to any cause within 12 months from the last dose of Trastuzumab for every participant
measure: Overall Survival (OS)
timeFrame: Time from the date of first study treatment until date of death, regardless of the cause of death within 12 months from the last dose of Trastuzumab for every participant. The follow up period was 52 weeks from the last dose of treatment in both arms.
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Yashoda Hospital
state: Andhra Pradesh
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Institute & Research Center
state: Delhi
city: Bangalore
country: India
facility: Manipal Hospital; Department of Oncology
state: Karnataka
city: Pune
country: India
facility: Jehangir Clinical Development Centre Pvt. Ltd; Cancer Research Room
state: Maharashtra
city: Delhi
country: India
facility: MAX Balaji Hospital
city: Trichy
country: India
facility: Dr. GVN Cancer Institute; Medical Oncology
Study officials:
affiliation: Roche Products (India) Pvt. Ltd.
name: Anil Kukreja, MD
role: STUDY_DIRECTOR
References: