Trial Evaluating Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer

Novartis

Status and phase: Terminated; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Drug: Fulvestrant; Drug: Dovitinib Placebo; Drug: Dovitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01528345

2011-001230-42 (EudraCT Number)

CTKI258A2210

Details and patient eligibility

About

This trial is designed to enroll postmenopausal patients with locally advanced or metastatic, HER2- and HR+ breast cancer not amenable to curative treatment by surgery or radiotherapy, and whose disease has progressed on or after prior endocrine therapy.

Patients must undergo molecular pre-screening prior to entry.

Enrollment: 97 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal women with HER2-, HR+ locally advanced or metastatic breast cancer
• Progression on or after endocrine treatment
• Measureable disease as per RECIST
• ECOG 0, 1 or 2

Exclusion criteria

• Evidence of CNS or leptomeningeal metastases
• Previous treatment with fulvestrant
• Previous chemotherapy for locally advanced or metastatic breast cancer
• Cirrhosis or chronic active/persistent hepatitis

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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97 participants in 2 patient groups, including a placebo group

Fulvestrant + Dovitinib active

Experimental group

Description:

Fulvestrant in combination with the study drug Dovitinib.

Treatment:

Drug: Dovitinib

Drug: Fulvestrant

Fulvestrant + Dovitinib placebo

Placebo Comparator group

Description:

Fulvestrant in combination with a placebo matching Dovitinib.

Treatment:

Drug: Dovitinib Placebo

Drug: Fulvestrant