- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00444587
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)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Sofia, Bulgaria, 1527
-
-
-
-
-
Tallinn, Estonia, 13419
-
-
-
-
-
Budapest, Hungary, 1115
-
Budapest, Hungary, 1125
-
Budapest, Hungary, 1122
-
Budapest, Hungary, 1135
-
Budapest, Hungary, 1145
-
Budapest, Hungary, 1082
-
Debrecen, Hungary, 4032
-
Gyor, Hungary, 9023
-
Gyula, Hungary, 5700
-
Nyíregyháza, Hungary, 4400
-
Szeged, Hungary, 6725
-
Szekesfehervar, Hungary, 8000
-
Szombathely, Hungary, 9700
-
-
-
-
-
Haifa, Israel, 31096
-
Holon, Israel, 58100
-
Petach Tikva, Israel, 49100
-
Ramat Gan, Israel, 52621
-
Rehovot, Israel, 76100
-
Safed, Israel, 13110
-
Tel Aviv, Israel, 6423906
-
Zerifin, Israel, 70300
-
-
-
-
-
Kaunas, Lithuania, 50009
-
Vilnius, Lithuania, 08660
-
-
-
-
-
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
-
-
-
-
-
Bratislava, Slovakia, 812 50
-
Kosice, Slovakia, 041 90
-
-
-
-
-
Adana, Turkey, 01330
-
Ankara, Turkey, 06590
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Trastuzumab + 2nd Line Chemotherapy
|
As prescribed
6mg/kg iv every 3 weeks
|
ACTIVE_COMPARATOR: Only Chemotherapy
|
As prescribed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median Time to Disease Progression
Time Frame: Up to 5 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate
Time Frame: Up to 5 years
|
Objective response rate (ORR) is defined as the percentage of participants with tumor shrinkage of a predefined amount.
It is a combination of complete response (CR) and partial response (PR) and was assessed according to the RECIST criteria 1.0.
Complete response refers to the disappearance of all target lesions and all non-target non-measurable lesions.
Partial Response refers to an at least 30 percent decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter.
Objective response rate 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
|
Clinical Benefit Rate
Time Frame: Up to 5 years
|
Clinical benefit rate (CBR) was defined as the percentage of participants taking a benefit from the treatments.
CBR includes 1) Complete response (CR): disappearance of all target lesions and all non-target non-measurable lesions 2) Partial response (PR) : >=30% decrease in the sum of the longest diameter of target lesions and 3) Stable disease (SD): non-PR and non-progressive disease.
It was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by CT or MRI by the investigator.
CBR was also assessed by computer.
Clinical benefit rate 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
|
Median Time to Treatment Failure
Time Frame: Up to 5 years
|
Time to treatment failure is defined as a composite endpoint measuring time (number of days) from enrollment to discontinuation of treatment or change in treatment for any reason, including disease progression, treatment toxicity and death.
Median time to treatment failure 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
|
Overall Survival
Time Frame: Up to 5 years
|
Overall Survival is defined as the time (number of days) between enrollment and the date of death due to any cause.
Overall survival 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
|
Number of Participants With Any Adverse Events and Serious Adverse Events
Time Frame: Up to 5 years
|
An adverse event (AE) is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
|
Up to 5 years
|
Biochemistry Safety Laboratory Parameters: Mean Serum Glutamic Oxaloacetic Transaminase, Serum Glutamic-pyruvic Transaminase and Alkali Phosphatase Levels
Time Frame: Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study Assessments (Up to 5 years)
|
Participants in the study were evaluated for the serum glutamic oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) and alkali phosphatase (ALP) at Visit 1 and final study assessments (Up to 5 years).
Serum glutamic oxaloacetic transaminase, Serum glutamic-pyruvic transaminase and Alkali Phosphatase levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
|
Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study Assessments (Up to 5 years)
|
Biochemistry Safety Laboratory Parameters: Mean Total Bilirubin and Serum Creatinine Levels
Time Frame: Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study Assessments (Up to 5 years)
|
Participants in the study were evaluated for the total bilirubin and serum creatinine.
Total Bilirubin and serum creatinine levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
|
Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study Assessments (Up to 5 years)
|
Biochemistry Safety Laboratory Parameters: Mean Albumin Levels
Time Frame: Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study assessments (Up to 5 years)
|
Participants in the study were evaluated for the albumin at Visit 1 and Final study assessments.
Albumin levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
|
Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study assessments (Up to 5 years)
|
Biochemistry Safety Laboratory Parameters: Mean Urea, Sodium and Potassium Levels
Time Frame: Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study assessments (Up to 5 years)
|
Participants in the study were evaluated for the biochemical safety laboratory parameters urea, sodium and potassium.
Urea, sodium and potassium levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
|
Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study assessments (Up to 5 years)
|
Hematology Safety Laboratory Parameters: Mean Hemoglobin Levels
Time Frame: Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)
|
Participants in the study were evaluated for the Hemoglobin up to 5 years.
Hemoglobin levels were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
|
Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)
|
Hematology Safety Laboratory Parameters: Mean Total Leukocytes Counts
Time Frame: Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)
|
Participants in the study were evaluated for the total leukocytes up to 5 years.
Total leukocytes counts were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
|
Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)
|
Hematology Safety Laboratory Parameters: Percent of Differential for Neutrophils, Basophils, Eosinophils, Lymphocytes and Monocytes Counts
Time Frame: Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)
|
Participants in the study were evaluated for the Neutrophils, Basophils, Eosinophils, Lymphocytes and Monocytes at Visit 1 and final study assessments. Neutrophils, Basophils, Eosinophils, Lymphocytes and Monocytes counts were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice. |
Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)
|
Hematology Safety Laboratory Parameter: Mean Platelets Counts
Time Frame: Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)
|
Participants in the study were evaluated for the platelets at Visit 1 and final study assessments.
Platelet counts were not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
|
Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)
|
Mean Left Ventricular Ejection Fraction
Time Frame: Visit 0 [Screening period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years).
|
Left ventricular ejection fraction (LVEF) is a measure of the percent of blood ejected from the ventricle in one heartbeat.
It is a measure of cardiac function and was assessed by echocardiogram or multigated angiogram at Visit 0 [Screening period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years).
|
Visit 0 [Screening period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML19944
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
Clinical Trials on Second line chemotherapy
-
Shanghai Gynecologic Oncology GroupZhejiang Cancer Hospital; Sun Yat-sen University; Fudan University; Shanghai Zhongshan...Active, not recruitingFallopian Tube Carcinoma | Ovarian Epithelial Cancer Recurrent | Primary Peritoneal CarcinomaChina
-
Boehringer IngelheimCompleted
-
Insel Gruppe AG, University Hospital BernEuropean Organisation for Research and Treatment of Cancer - EORTCRecruitingGlioblastomaGermany, Switzerland, Austria, Greece, Italy, Portugal, Romania
-
Peking University People's HospitalPeking University Shougang HospitalCompletedPrognosis | Clinical Response | Histopathological ResponseChina
-
Nanfang Hospital of Southern Medical UniversityRecruitingThe Effects of RFA in Combination With Second-line Chemotherapy and Bevacizumab on Unresectable CRLMColorectal Neoplasms MalignantChina
-
National Cancer Institute, NaplesActive, not recruiting
-
Georgetown UniversityCedars-Sinai Medical Center; Thomas Jefferson University; Sinai Health System; George... and other collaboratorsWithdrawnMetastatic Pancreatic CancerUnited States
-
Genentech, Inc.CompletedBrain Neoplasms | Non-Small Cell Lung Cancer
-
AstraZenecaQuintiles, Inc.CompletedNSCLCBulgaria, France, Italy, Mexico, Peru, Russian Federation, Spain, Turkey, United Kingdom, Sweden, Poland, Ukraine, Chile, Hungary, Israel, Netherlands, Portugal, Romania, Germany, Austria, Belgium, Canada, Australia
-
Sun YanPeking University; Peking University Cancer Hospital & InstituteUnknownHead and Neck NeoplasmsChina