Phase Ib/II trial of BEZ235 with paclitaxel in patients with HER2 negative, locally advanced or metastatic breast cancer

Conditions: Adult female patients with HER2 negative breast cancer which is found to be inoperable locally advanced or metastatic disease
MedDRA version: 14.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2011-002400-32-ES

Lead Sponsor: ovartis Farmacéutica, S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 230

Inclusion Criteria

Inclusion criteria applicable to Phase Ib and II:
?Patient is a female ? 18 years of age.
?Patient has a histologically and/or cytologically confirmed diagnosis of breast cancer.
?Patient has radiological evidence of inoperable locally advanced or metastatic breast cancer.
?Patient has HER2 negative disease.
?Patient has adequate bone marrow and organ function.

Additional criteria for Phase II:
?Patient has a known PI3K status (activated or wildtype) based on results from a Novartis designated laboratory prior to start of treatment.
?Patient has recent radiological documentation of recurrent disease or newly diagnosed disease.
?Patient has at least one measurable lesion as per RECIST 1.1.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 170

Exclusion Criteria

Exclusion criteria applicable for Phase Ib and II:
?Patient has received previous treatment with PI3K and/or mTOR pathway inhibitors.
?Patient has active uncontrolled or symptomatic central nervous system (CNS) metastases.
?Patient has received wide field radiotherapy or irradiation of ? 25% of the bone marrow ? 28 days or limited field radiation for palliation ? 14 days prior to starting study drug or has not recovered from side effects of such therapy.
?Patient has active cardiac disease or a history of cardiac dysfunction.
?Patient has a family history of congenital long or short QT, or known history of QT/QTc prolongation or Torsades de Pointes (TdP).
?Patient has inadequately controlled hypertension (i.e., SBP>180 mmHg or DBP>100mmHg).
?Patient has uncontrolled diabetes mellitus.
?Patient has impairment of GI function or GI disease that may significantly alter the absorption of BEZ235 and/ or paclitaxel.

Additional exclusion criterion for Phase II:
?Patient has received any prior chemotherapies for the inoperable locally advanced or metastatic disease.

Other protocol-defined inclusion/exclusion criteria may apply.