Clinical Trials Logo
  1. Home
  2. Neoplasms, Breast
  3. NCT01160211

A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer

Neoplasms, Breast Clinical Trial

Official title:
A Phase III Trial to Compare the Safety and Efficacy of Lapatinib Plus Trastuzumab Plus an Aromatase Inhibitor (AI) vs. Trastuzumab Plus an AI vs. Lapatinib Plus an AI as 1st- or 2nd- Line Therapy in Postmenopausal Subjects With Hormone Receptor+, HER2-positive Metastatic Breast Cancer (MBC) Who Received Prior Trastuzumab and Endocrine Therapies

Clinical Trial Summary

A study to compare the safety and efficacy of an aromatase inhibitor in combination with lapatinib, trastuzumab or both for the treatment of hormone receptor positive, HER2+ metastatic breast cancer (MBC).

Clinical Trial Description

This was a Phase III, randomized, open-label, multi-center, three arm study of lapatinib plus trastuzumab plus an aromatase inhibitor (AI), trastuzumab plus an AI, or lapatinib plus an AI to evaluate the efficacy and safety of these regimens as first- or second-line therapy in postmenopausal subjects with hormone receptor positive (HR+), HER2-positive metastatic breast cancer (MBC) who have received prior trastuzumab and endocrine therapies. Eligible subjects was postmenopausal; had tumors that are ER and/or PgR positive and HER2-positive; had Stage IV metastatic breast cancer. The primary objective was to demonstrate superiority of lapatinib/trastuzumab/AI combination versus (vs.) trastuzumab/AI combination for progression free survival. The secondary objectives were to evaluate progression free survival in trastuzumab/AI vs. lapatinib/AI and trastuzumab/lapatinib/AI vs. lapatinib/AI, overall survival, overall response rate, clinical benefit rate, the safety and tolerability of all three treatment groups (lapatinib plus trastuzumab plus an AI, trastuzumab plus an AI, or lapatinib plus an AI), and quality of life status relative to baseline. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01160211
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 3
Start date May 5, 2011
Completion date June 6, 2022
View Details
See also
  Status Clinical Trial Phase
Terminated NCT00251433 - GW572016 With Docetaxel and Trastuzumab for the Treatment Of Untreated ErbB2 Over-Expressing Metastatic Breast Cancer Phase 1
Completed NCT01271738 - Evaluating and Comparing Two Surgical Methods for Treatment of Early Stage Breast Cancer N/A
Recruiting NCT04892342 - Study of ESG401 in Adults With Solid Tumors Phase 1/Phase 2
Terminated NCT02213042 - Evaluation of Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer Phase 2
Withdrawn NCT01137994 - A Phase II, Randomized, Open-label Study of Lapatinib Plus Chemotherapy Versus Trastuzumab Plus Chemotherapy in HER2-positive and p95HER2-positive Metastatic Breast Cancer Phase 2
Completed NCT00790816 - Continuation Study of Lapatinib Monotherapy or Lapatinib in Combination With Other Anti-cancer Agents Phase 1
Completed NCT00051103 - Oral Drug Study In Women With Refractory Metastatic Breast Cancer After First-line or Second-line Herceptin. Phase 2
Completed NCT00320411 - GW572016 In Patients With ErbB2 Over - Expressing Advanced Or Metastatic Breast Cancer Phase 2
Completed NCT00258050 - To Examine The Effects Of Lapatinib On Orally And Intravenously Administered Midazolam In Cancer Patients Phase 1
Terminated NCT01498588 - Trial of Eribulin Followed by Doxorubicin & Cyclophosphamide for Her2-negative, Locally Advanced Breast Cancer Phase 2
Terminated NCT00479856 - Lapatinib In Combination With Chemotherapy In Subjects With Relapsed Breast Cancer Phase 2
Completed NCT00320385 - Lapatinib In Combination With Trastuzumab Versus Lapatinib Monotherapy In Subjects With HER2-positive Metastatic Breast Cancer Phase 3
Completed NCT00062686 - GW572016 For Treatment Of Refractory Metastatic Breast Cancer Phase 2
Completed NCT00996762 - A Study in Cancer Patients to Evaluate the Bioequivalence of Alternative Formulations of Lapatinib Phase 1
Terminated NCT02913729 - Pre- Versus Postoperative Accelerated Partial Breast Irradiation N/A
Recruiting NCT05814224 - Monitoring luminAl Breast Cancer Through the Evaluation of Mutational and epiGeNEtic alteraTIons of Circulating ESR1 DNA N/A
Completed NCT01815294 - A Pivotal Bioequivalence Study of DOXIL/CAELYX (Doxorubicin HCL) in Patients With Advanced or Refractory Solid Malignancies Including Patients With Ovarian Cancer Phase 1
Terminated NCT00437073 - Brain Metastases In ErbB2-Positive Breast Cancer Phase 2
Completed NCT00356811 - Lapatinib Combined With Paclitaxel For Patients With First-Line ErbB2-Amplified Metastatic Breast Cancer Phase 2
Completed NCT00490139 - ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D Phase 3