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A Phase Ib/II, Open Label, Multi-center Study Evaluating the Safety and Efficacy of BKM120 in Combination With Trastuzumab in Patients With Relapsing HER2 Overexpressing Breast Cancer Who Have Previously Failed Trastuzumab

Phase 1
18 Years
Open (Enrolling)
Metastatic Breast Cancer, Trastuzumab, BKM120, HER2+

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Trial Information

A Phase Ib/II, Open Label, Multi-center Study Evaluating the Safety and Efficacy of BKM120 in Combination With Trastuzumab in Patients With Relapsing HER2 Overexpressing Breast Cancer Who Have Previously Failed Trastuzumab

Inclusion Criteria:

- 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
- 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

- Patients with any peripheral neuropathy ≥ Common Terminology Criteria for Adverse
Events (CTCAE) grade 2

- Patients with a history of mood disorders or ≥ CTCAE grade 3 anxiety

- Patient with clinical manifest diabetes mellitus or steroid-induced diabetes mellitus

// Specific Exclusion Criteria for patients in BM cohorts

- Prior treatment with capecitabine

- Patient has known dihydropyrimidine dehydrogenase (DPD) deficiency

- Patient is currently receiving treatment with EIAED

- Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse event frequencies by patient and DLT frequencies by cohort

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

May 2010

Completion Date:

June 2014

Related Keywords:

  • Metastatic Breast Cancer
  • Trastuzumab
  • BKM120
  • Her2+
  • HER2
  • BKM120
  • PIK3
  • metastatic breast cancer
  • brain metastases
  • Herceptin
  • trastuzumab
  • capecitabine
  • open-label
  • maximum tolerated dose
  • Phase I
  • Breast Neoplasms



Horizon Oncology CenterLafayette, Indiana  47905
Ironwood Cancer and Research Centers IronwoodChandler, Arizona  85224
Highlands Oncology Group Dept of Highlands Oncology GrpFayetteville, Arkansas  72703
The West Clinic Dept. of the West ClinicMemphis, Tennessee  38120
Wayne State University/Karmanos Cancer Institute Dept.of KarmanosCancerInst (6)Detroit, Michigan  48201
University of Alabama at Birmingham/ Kirklin Clinic Univ AL - PIBirmingham, Alabama  35294-0006
Memorial Regional Cancer Center Memorial BreastHollywood, Florida  33021
H. Lee Moffitt Cancer Center/University of South FloridaTampa, Florida  33612
Palm Beach Cancer Institute PB CancerWest Palm Beach, Florida  33401
Rush University Medical Center Study CoordinatorChicago, Illinois  60612
Ingalls Memorial Hospital Ingalls Mem HospHarvey, Illinois  60426
Washington University School Of Medicine-Siteman Cancer Ctr WA SitemanSt. Louis, Missouri  63110
Beth Israel Medical Center BIMCNew York, New York  10003
Duke University Medical Center Duke South 2Durham, North Carolina  27710
Sarah Cannon Research Institute Sarah Cannon Cancer Center SCNashville, Tennessee  37203
Cancer Therapy & Research Center / UT Health Science Center CTRC at the UTHSCSA (2)San Antonio, Texas  78229
Seattle Cancer Care Alliance/Fred Hutchinson Cancer Research SCCA - Freh HutchSeattle, Washington  98109-1023
University of Wisconsin Univ WiscMadison, Wisconsin  53792
University of California at Los Angeles UCLA LeConte LocationLos Angeles, California  90095