Clinical trial NCT00444587: A Study of Herceptin (Trastuzumab) in Combination With 2nd-Line Chemotherapy in Patients With HER2 Positive Metastatic Breast Cancer.
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-03-08
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Median Time to Disease Progression
timeFrame: Up to 5 years
Secondary outcomes:
measure: Objective Response Rate
timeFrame: Up to 5 years
measure: Clinical Benefit Rate
timeFrame: Up to 5 years
measure: Median Time to Treatment Failure
timeFrame: Up to 5 years
measure: Overall Survival
timeFrame: Up to 5 years
measure: Number of Participants With Any Adverse Events and Serious Adverse Events
timeFrame: Up to 5 years
measure: Biochemistry Safety Laboratory Parameters: Mean Serum Glutamic Oxaloacetic Transaminase, Serum Glutamic-pyruvic Transaminase and Alkali Phosphatase Levels
timeFrame: Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study Assessments (Up to 5 years)
measure: Biochemistry Safety Laboratory Parameters: Mean Total Bilirubin and Serum Creatinine Levels
timeFrame: Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study Assessments (Up to 5 years)
measure: Biochemistry Safety Laboratory Parameters: Mean Albumin Levels
timeFrame: Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study assessments (Up to 5 years)
measure: Biochemistry Safety Laboratory Parameters: Mean Urea, Sodium and Potassium Levels
timeFrame: Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study assessments (Up to 5 years)
measure: Hematology Safety Laboratory Parameters: Mean Hemoglobin Levels
timeFrame: Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)
measure: Hematology Safety Laboratory Parameters: Mean Total Leukocytes Counts
timeFrame: Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)
measure: Hematology Safety Laboratory Parameters: Percent of Differential for Neutrophils, Basophils, Eosinophils, Lymphocytes and Monocytes Counts
timeFrame: Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)
measure: Hematology Safety Laboratory Parameter: Mean Platelets Counts
timeFrame: Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years)
measure: Mean Left Ventricular Ejection Fraction
timeFrame: Visit 0 [Screening period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years).
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
city: Tallinn
country: Estonia
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Gyor
country: Hungary
city: Gyula
country: Hungary
city: Nyíregyháza
country: Hungary
city: Szeged
country: Hungary
city: Szekesfehervar
country: Hungary
city: Szombathely
country: Hungary
city: Haifa
country: Israel
city: Holon
country: Israel
city: Petach Tikva
country: Israel
city: Ramat Gan
country: Israel
city: Rehovot
country: Israel
city: Safed
country: Israel
city: Tel Aviv
country: Israel
city: Zerifin
country: Israel
city: Kaunas
country: Lithuania
city: Vilnius
country: Lithuania
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
city: Bratislava
country: Slovakia
city: Kosice
country: Slovakia
city: Adana
country: Turkey
city: Ankara
country: Turkey
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: