Adjuvant Trastuzumab, Pertuzumab Plus Docetaxel in the Treatment of Early HER2-positive Breast Cancer (BOLD-1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02625441|
Recruitment Status : Recruiting
First Posted : December 9, 2015
Last Update Posted : August 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Pertuzumab Drug: Trastuzumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1366 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase III Study Comparing Trastuzumab, Pertuzumab Plus Docetaxel (TPD) Followed by 3 Cycles of Chemotherapy to the Current Standard Regimen as the Treatments of Early Breast Cancer|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||June 2023|
Experimental: Short anti-HER2 treatment
Pertuzumab 840 mg, i.v., then 420 mg i.v., 3-weekly for 3 cycles; Trastuzumab 8 mg/kg, i.v., then 6 mg/kg, 3-weekly for 3 cycles; Docetaxel 75 mg/m2, i.v., 3-weekly for 3 cycles
Pertuzumab 420 mg i.v. 3-weekly for 3 cycles
Other Name: Perjeta
Active Comparator: Standard anti-HER2 treatment
Trastuzumab 8 mg/kg, i.v., then 6 mg/kg, 3-weekly for 3 cycles; Docetaxel 75 mg/m2, i.v., 3-weekly for 3 cycles; Trastuzumab 6 mg/kg, i.v., 3-weekly for for a total duration of one year
Trastuzumab 6 mg/kg, i.v., 3-weekly for for a total duration of one year
Other Name: Herceptin
- Invasive disease-free survival [ Time Frame: 7 years ]Time from the date of randomization to cancer recurrence or death.
- Overall survival [ Time Frame: 7 years ]Time from the date of randomization to death.
- Distant disease-free survival [ Time Frame: 7 years ]Time from the date of randomization to distant recurrence of cancer or to death.
- Left ventricle ejection fractions [ Time Frame: 3 years ]Cardiac ejection fraction measured with echocardiography or isotope cardiography.
- Adverse events of the treatments [ Time Frame: 7 years ]Adverse events considered to be related to the treatments.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02625441
|Contact: Heikki Joensuu, M.D.||094711 ext +email@example.com|
|Helsinki University Central Hospital||Recruiting|
|Helsinki, Finland, 00029|
|Contact: Heikki Joensuu, MD 47173200 ext 09 firstname.lastname@example.org|
|Contact: Raija 09 Husa 4711 ext 09 email@example.com|
|Principal Investigator:||Heikki Joensuu, M.D.||Helsinki University Central Hospital|