Phase 1b/2 Study of BKM120 Plus Trastuzumab in Patients With HER2-positive Breast Cancer

Stopped early · Phase 1/Phase 2

Conditions studied: Metastatic Breast Cancer, HER2+ Breast Cancer

In brief

This study will assess the safety and efficacy of BKM120 in combination with trastuzumab in patients with relapsing HER2 overexpressing breast cancer who have previously failed trastuzumab. The study will further assess the safety and preliminary efficacy of BKM120 in combination with trastuzumab and capecitabine in patients with relapsing HER2 overexpressing breast cancer and brain metastases (BM) who have previously failed trastuzumab.

Key facts

Study ID

NCT01132664

Run by

Novartis Pharmaceuticals

People needed

72

Starts

2010-05-01

Expected to finish

2014-08-01

Last updated by the study team

2016-08-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• World Health Organization (WHO) Performance Status of ≤ 2
• Patients with HER2+ breast cancer by local laboratory testing (immunohistochemistry [IHC] 3+ staining or fluorescence in situ hybridization [FISH] confirmation for IHC 2+ and 1+)
• Documented tumor resistance to trastuzumab:
• Recurrence while on trastuzumab or within 12 months since the last infusion for patients who received trastuzumab as adjuvant treatment
• Progression while on or within 4 weeks since the last infusion of trastuzumab for patients who received trastuzumab for metastatic disease.
• Documented evidence of progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) on trastuzumab-based therapy defined as:
• Phase Ib: at any time before study entry
• Phase II: within 16 weeks before date of first dosing
• Received at least 1 but no more than 4 prior anit-HER2 based regimens including at least 1 regimen containing trastuzumab (adjuvant or neo-adjuvant trastuzumab will be considered as one prior regimen). HER2 directed therapies are defined as comprising trastuzumab, lapatinib, and trastuzumab-DM1 (T-DM1) only.
• Phase II only: trastuzumab, T-DM1 or lapatinib must be part of the most recent line of therapy
• Previous lines of cytotoxic chemotherapy:
• Phase Ib: no more than 4 lines of cytotoxic chemotherapy
• Phase II: no more than 3 lines of cytotoxic chemotherapy
• Measurable disease:
• Phase Ib: patient has at least one measurable lesion or non-measurable disease as defined per RECIST
• Phase II: patient has at least one measureable lesion as defined per RECIST
• \|\| Specific Inclusion Criteria for patients in BM cohorts:
• Patient has evidence of progressing brain metastases and/or new metastatic brain lesion(s) without leptomeningeal disease.
• Patient has received prior WBRT and/or SRS at at >28 and >/= 14 days, respectively, prior to starting study drug and the patient must have recovered from the side effects of the therapy
• WHO performance status of </=1
• PT INR </= 1.5
• Any number of prior HER2-directed and cytotoxic regimens, and the most recent line may be any type of anti-neoplastic therapy
• \|\| Exclusion Criteria:
• Patients with untreated brain metastases
• Patients with acute or chronic liver, renal disease or pancreatitis

Where it is running

• University of Alabama at Birmingham/ Kirklin Clinic Univ AL - PI — Birmingham, Alabama, United States
• Highlands Oncology Group Dept of Highlands Oncology Grp — Fayetteville, Arkansas, United States
• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• Karmanos Cancer Institute Dept.of KarmanosCancerInst (6) — Detroit, Michigan, United States
• Washington University School Of Medicine-Siteman Cancer Ctr WA Siteman — St Louis, Missouri, United States
• Beth Israel Medical Center BIMC — New York, New York, United States
• Sarah Cannon Research Institute Sarah Cannon Cancer Center SC — Nashville, Tennessee, United States
• Novartis Investigative Site — Liège, Belgium
• Novartis Investigative Site — Wilrijk, Belgium
• Novartis Investigative Site — Lyon, France
• Novartis Investigative Site — Saint-Herblain Cédex, France
• Novartis Investigative Site — Cagliari, CA, Italy
• Novartis Investigative Site — Province of Macerata, MC, Italy
• Novartis Investigative Site — Modena, MO, Italy
• Novartis Investigative Site — Terni, TR, Italy
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — L'Hospitalet de Llobregat, Catalonia, Spain
• Novartis Investigative Site — Valencia, Valencia, Spain
• Novartis Investigative Site — Brighton, East Sussex, United Kingdom
• Novartis Investigative Site — Nottingham, United Kingdom
• Novartis Investigative Site — Oxford, United Kingdom

Full record on ClinicalTrials.gov

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