Clinical Trial: NCT03272477
Study to Compare Neoadjuvant Combination of Trastuzumab and Pertuzumab With Concurrent Taxane Chemotherapy or Endocrine Therapy and Quality of Life Assessment Under Adjuvant Therapy in Operable HER2+/HR+ Breast Cancer Patients
Status:
COMPLETEDPhase:
Phase 2| Lead Sponsor: | Palleos Healthcare GmbH |
| Information Provided By: | Palleos Healthcare GmbH |
| Last Update Posted: | 2024-04-17 |
Study Overview
Brief Summary
This is a prospective, phase IIa, multicenter, randomized, open-label study comparing a pre-surgical combination of trastuzumab and pertuzumab with concurrent weekly paclitaxel chemotherapy or endocrine therapy given for 12 weeks with a quality of life assessment for 40 additional weeks in patients with operable HER2+/HR+ breast cancer.
Official Title
A Prospective, Randomized, Multicenter, Open-label Comparison of Pre-surgical Combination of Trastuzumab and Pertuzumab With Concurrent Taxane Chemotherapy or Endocrine Therapy Given for Twelve Weeks With a Quality of Life Assessment of Trastuzumab, Pertuzumab in Combination With Standard (Neo)Adjuvant Treatment in Patients With Operable HER2+/HR+ Breast Cancer.
Conditions
Breast Neoplasms
Intervention / Treatment
- Drug: Perjeta Injectable Product
- Drug: Herceptin
- Drug: Tamoxifen
- Drug: Paclitaxel
- Drug: Epirubicin
- Drug: Cyclophosphamide
- Drug: Anastrozole
- Drug: Letrozole
- Drug: Exemestane
- Drug: Leuprorelin acetate
- Drug: Goserelin
- Drug: Anastrozole
- Drug: Letrozole
- Drug: Exemestane
- Drug: Paclitaxel
- Drug: Tamoxifen
- Drug: Leuporelin acetate
- Drug: Goserelin
- Diagnostic Test: Biopsy
- Procedure: Surgery
Other Study ID Numbers
- PH002-TP-II
Start Date (Actual)
2017-10-05
Primary Completion Date (Actual)
2020-07-14
Study Completion Date (Actual)
2024-03-04
Enrollment (Actual)
257
Study Type
Interventional
Phase
Phase 2
| Lead Sponsor: | Palleos Healthcare GmbH |
| Information Provided By: | Palleos Healthcare GmbH |
| Last Update Posted: | 2024-04-17 |
Study Overview
Brief Summary
This is a prospective, phase IIa, multicenter, randomized, open-label study comparing a pre-surgical combination of trastuzumab and pertuzumab with concurrent weekly paclitaxel chemotherapy or endocrine therapy given for 12 weeks with a quality of life assessment for 40 additional weeks in patients with operable HER2+/HR+ breast cancer.
Official Title
A Prospective, Randomized, Multicenter, Open-label Comparison of Pre-surgical Combination of Trastuzumab and Pertuzumab With Concurrent Taxane Chemotherapy or Endocrine Therapy Given for Twelve Weeks With a Quality of Life Assessment of Trastuzumab, Pertuzumab in Combination With Standard (Neo)Adjuvant Treatment in Patients With Operable HER2+/HR+ Breast Cancer.
Conditions
Breast Neoplasms
Intervention / Treatment
- Drug: Perjeta Injectable Product
- Drug: Herceptin
- Drug: Tamoxifen
- Drug: Paclitaxel
- Drug: Epirubicin
- Drug: Cyclophosphamide
- Drug: Anastrozole
- Drug: Letrozole
- Drug: Exemestane
- Drug: Leuprorelin acetate
- Drug: Goserelin
- Drug: Anastrozole
- Drug: Letrozole
- Drug: Exemestane
- Drug: Paclitaxel
- Drug: Tamoxifen
- Drug: Leuporelin acetate
- Drug: Goserelin
- Diagnostic Test: Biopsy
- Procedure: Surgery
Other Study ID Numbers
- PH002-TP-II
Start Date (Actual)
2017-10-05
Primary Completion Date (Actual)
2020-07-14
Study Completion Date (Actual)
2024-03-04
Enrollment (Actual)
257
Study Type
Interventional
Phase
Phase 2