Elderly Metastatic Breast Cancer: Pertuzumab-Herceptin vs Pertuzumab-Herceptin-Metronomic Chemotherapy, Followed by T-DM1
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|ClinicalTrials.gov Identifier: NCT01597414|
Recruitment Status : Active, not recruiting
First Posted : May 14, 2012
Last Update Posted : February 15, 2021
Chemotherapy and HER2 targeted agents can improve survival significantly in metastatic breast cancer. Chemotherapy however is associated with significant side-effects and can impact on Quality of Life and functionality in older patients.
The investigators aim to establish HER2 targeted regimens with minimal toxicity in order to delay or even avoid the use of classical chemotherapy because of competing risks of death in this frail/elderly patient group.
|Condition or disease||Intervention/treatment||Phase|
|Elderly Metastatic Breast Cancer Population||Drug: Pertuzumab + trastuzumab Drug: Pertuzumab + trastuzumab + metronomic chemotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pertuzumab + Trastuzumab (PH) Versus PH Plus Metronomic Chemotherapy (PHM) in the Elderly HER2+ Metastatic Breast Cancer Population Who May Continue on T-DM1 Alone Following Disease Progression While on PH / PHM: an Open-label Multicentre Randomized Phase II Selection Trial of the EORTC Elderly Task Force and Breast Cancer Group|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||June 2021|
Active Comparator: Pertuzumab + trastuzumab (PH)
Pertuzumab + trastuzumab. After progression,patients will be given the option of receiving T-DM1
Drug: Pertuzumab + trastuzumab
Trastuzumab: loading dose of 8 mg/kg of body weight on cycle 1, followed by a maintenance dose of 6 mg/kg every 3 weeks.
Pertuzumab: loading dose of 840 mg on cycle 1, followed by 420 mg for subsequent cycles, every 3 weeks.
if T-DM1: 3.6 mg/kg IV, every 3 weeks.
Experimental: PH + metronomic chemotherapy (PHM)
Pertuzumab + trastuzumab + metronomic chemotherapy. After progression,patients will be given the option of receiving T-DM1
Drug: Pertuzumab + trastuzumab + metronomic chemotherapy
Pertuzumab and trastuzumab will be administered as in arm A. Cyclophosphamide: daily dose of 50 mg/day. if T-DM1: as in arm A
- Progression free survival rate [ Time Frame: 6 months after patients in ]
- Overall survival
- Breast cancer specific survival
- Tumor response rate as measured by RECIST v1.1
- Evolution of HRQoL as assessed by EORTC QLQ-C30 and ELD 14 [ Time Frame: Up to 1 year after treatment start ]
- Evolution of geriatric assessment [ Time Frame: Up to 1 year after treatment start ]
- if T-DM1: progression free survival rate [ Time Frame: 6 months after start of T-DM1 treatment ]
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): NCT01597414
|Study Chair:||Hans Wildiers, MD||UZ Leuven, Leuven, Belgium|