NCT01050322: GLICO-0801

A Randomized Open-Label, Phase II Study of Lapatinib-capecitabine or Lapatinib-vinorelbine or Lapatinib/Gemcitabine in Subjects With Her2/Neu Amplified Metastatic Breast Cancer Patients Progression After Taxanes Treatment

Completed Phase 2 Last updated 4 June 2013

What this trial tests

Phase 2 trial testing Lapatinib Vinorelbine in BRMS1 in 142 participants. Completed in 1 September 2011.

Timeline

1 November 2009

Primary endpoint
1 December 2010

1 September 2011

Quick facts

Lead sponsor	Latin American Cooperative Oncology Group
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	142
Start date	1 November 2009
Primary completion	1 December 2010
Estimated completion	1 September 2011
Sites	18 locations across Argentina, Brazil, Peru

Drugs / interventions tested

• Lapatinib Vinorelbine — full drug profile →
• Lapatinib Capecitabine
• Gemcitabine Lapatinib — full drug profile →

Conditions studied

• BRMS1 — all drugs for BRMS1 →
• Performance Status Zero to Two for Beginning the Study — all drugs for Performance Status Zero to Two for Beginning the Study →
• Patient With a Maximum of One Chemotherapy — all drugs for Patient With a Maximum of One Chemotherapy →
• Patient With Progression After Taxanes — all drugs for Patient With Progression After Taxanes →

Sponsor

Latin American Cooperative Oncology Group

Who can join

18 and older, any sex, with BRMS1 or Performance Status Zero to Two for Beginning the Study. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Clinical benefit rate
  Time frame: 6 months

Sponsor's own description

Despite these initial positive signals in recent statistics, breast cancer continues to claim a substantial number of lives approximately 500,000 deaths worldwide in 2005 Thus the current treatment paradigm - surgery, radiation and systemic chemo and or hormonal therapy and biological therapies -still fails to cure a significant number of women with early breast cancer and new treatment strategies are needed to improve current results both in early and advance disease.

Recurrent or metastatic breast cancer is an incurable malignancy with a median survival of 20-24 months \[Hortobagyi , 1998\] and this has not changed significantly over the last decade with fewer than 20% of patients still alive at 5 years after a diagnosis of recurrence. Although there have been small improvements in survival with the new therapies, metastatic breast cancer remains an incurable and, ultimately, fatal disease. The introduction of novel combination therapies have the potential to target different pathways in the cancer cell, leading to improved efficacy. Further studies to optimize combination therapy, while ameliorating AEs, are critically important to patients with metastatic breast cancer.

Lapatinib is an oral tyrosine kinase inhibitor which potently inhibits both EGFR and HER2\[Spector, 2005\]. Lapatinib in combination with capecitabine is approved in more than 20 countries for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2. All patients in the study leading to the lapatinib approval had received prior therapy including an anthracycline, a taxane, and trastuzumab.

The relevance of the HER2/neu target in breast cancer, combined with the promising preclinical and clinical data regarding the use of lapatinib, provide the rationale for a formal evaluation of this agent combined with other non taxane agents as gemcitabine or vinorelbine after progression on taxanes and trastuzumab based therapies in metastatic disease setting as these chemotherapy options are used in daily practice in this subset of patients.

This is a randomized phase II, open label,multicentric , international, 3 arms treatment study in patients with confirmed HER2+ metastatic breast cancer after taxane progression . The main objective is to investigate the (CBR) and safety in 3 different combinations of Lapatinib therapy (plus capecitabine or gemcitabine or vinorelbine) and to determine whether either, or both, of Lapatinib /Vinorelbine or Lapatinib/Gemcitabine can be considered a reasonable alternative to the established Lapatinib/Capecitabine standard combination . The decision as to whether to study either of the new combinations further will be based on both the toxicity and the efficacy profiles.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Unlocking New Avenues in Breast Cancer Treatment: The Synergy of Kinase Inhibitors and Immunotherapy.
   Bravo MJ, Burgos-Molina AM, García-Aranda M, Redondo M, et al · · 2023 · cited 5× · PMID 38067203 · DOI 10.3390/cancers15235499