A Study of Herceptin (Trastuzumab) in Combination With 2nd-Line Chemotherapy in Patients With HER2 Positive Metastatic Breast Cancer.
A Multicenter Phase II Trial of Trastuzumab (Herceptin) Continuation in Combination With 2nd-line Chemotherapies After Progression on a 1st-line Chemotherapy Combined With Trastuzumab in Patients With HER2 Positive Metastatic Breast Cancer (Treatment Beyond Progression, TBP)
1 other identifier
interventional
114
8 countries
30
Brief Summary
This 2 arm study will compare the efficacy and safety of continuation or discontinuation of Herceptin treatment in combination with 2nd line chemotherapy, in patients with HER2 positive metastatic breast cancer whose condition has progressed on 1st line chemotherapy plus Herceptin. Patients will be randomized either to continue or discontinue Herceptin treatment (6mg/kg iv infusion every 3 weeks) while receiving second-line chemotherapy of the investigator's choice. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 breast-cancer
Started Mar 2007
Typical duration for phase_2 breast-cancer
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 7, 2007
CompletedFirst Posted
Study publicly available on registry
March 8, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
June 21, 2016
CompletedJune 21, 2016
May 1, 2016
4.4 years
March 7, 2007
March 16, 2016
May 12, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Median Time to Disease Progression
Time to disease progression (TTP) in days was defined as the time from enrollment to objective disease progression (all categories other than objective disease progression was set to be censored including death before progression). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions. Tumor assessments were performed using computer tomography or magnetic resonance imaging. TTP as assessed by investigator, along with a recalculation done by computer algorithm is presented below. Median time was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
Up to 5 years
Secondary Outcomes (14)
Objective Response Rate
Up to 5 years
Clinical Benefit Rate
Up to 5 years
Median Time to Treatment Failure
Up to 5 years
Overall Survival
Up to 5 years
Number of Participants With Any Adverse Events and Serious Adverse Events
Up to 5 years
- +9 more secondary outcomes
Study Arms (2)
Trastuzumab + 2nd Line Chemotherapy
EXPERIMENTALOnly Chemotherapy
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- female patients, \>= 18 years of age;
- metastatic breast cancer;
- HER2 overexpression (IHC 3+ and/or FISH positive);
- disease progression during or after previous 1st line chemotherapy + Herceptin;
- scheduled to receive 2nd line chemotherapy.
You may not qualify if:
- concurrent immunotherapy or hormonal therapy;
- anthracyclines as part of previous 1st line chemotherapy or planned 2nd line chemotherapy;
- cardiac toxicity during previous 1st line chemotherapy + Herceptin;
- history of other malignancy within last 5 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Unknown Facility
Sofia, 1527, Bulgaria
Unknown Facility
Tallinn, 13419, Estonia
Unknown Facility
Budapest, 1082, Hungary
Unknown Facility
Budapest, 1115, Hungary
Unknown Facility
Budapest, 1122, Hungary
Unknown Facility
Budapest, 1125, Hungary
Unknown Facility
Budapest, 1135, Hungary
Unknown Facility
Budapest, 1145, Hungary
Unknown Facility
Debrecen, 4032, Hungary
Unknown Facility
Győr, 9023, Hungary
Unknown Facility
Gyula, 5700, Hungary
Unknown Facility
Nyíregyháza, 4400, Hungary
Unknown Facility
Szeged, 6725, Hungary
Unknown Facility
Székesfehérvár, 8000, Hungary
Unknown Facility
Szombathely, 9700, Hungary
Unknown Facility
Haifa, 31096, Israel
Unknown Facility
Holon, 58100, Israel
Unknown Facility
Petah Tikva, 49100, Israel
Unknown Facility
Ramat Gan, 52621, Israel
Unknown Facility
Rehovot, 76100, Israel
Unknown Facility
Safed, 13110, Israel
Unknown Facility
Tel Aviv, 6423906, Israel
Unknown Facility
Ẕerifin, 70300, Israel
Unknown Facility
Kaunas, 50009, Lithuania
Unknown Facility
Vilnius, 08660, Lithuania
Unknown Facility
Skopje, 1000, North Macedonia
Unknown Facility
Bratislava, 812 50, Slovakia
Unknown Facility
Košice, 041 90, Slovakia
Unknown Facility
Adana, 01330, Turkey (Türkiye)
Unknown Facility
Ankara, 06590, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roche Trial Information Hotline
- Organization
- F. Hoffmann-La Roche AG
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2007
First Posted
March 8, 2007
Study Start
March 1, 2007
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
June 21, 2016
Results First Posted
June 21, 2016
Record last verified: 2016-05