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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01528345
First received: January 31, 2012
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Metastatic Breast Cancer
Drug: Dovitinib
Drug: Fulvestrant
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase II Trial Evaluating the Safety and Efficacy of Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer That Have Evidence of Disease Progression on or After Prior Endocrine Therapy

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Every 8 weeks assessed up to 24 months ] [ Designated as safety issue: No ]
    PFS is defined as the date of randomization to the date of the first radiologically documented disease progression (PD) or death due to any cause per local investigator assessment as per RECIST.


Secondary Outcome Measures:
  • Overall Response Rate (ORR) [ Time Frame: Every 8 weeks assessed up to 24 months ] [ Designated as safety issue: No ]
    ORR is defined as the percentage of patients with a best overall response of Complete Response (CR) or Partial Response (PR) as per RECIST

  • Duration of Response (DOR) [ Time Frame: From date of first documented efficacy response (CR or PR) to time of documented progression (PD) whichever comes first, assessed up to 24 months ] [ Designated as safety issue: No ]
    DOR is defined as time from the date of the first documented response (CR or PR) to the date of the first documented or death due to disease. If a patient does not have a progression event, DOR will be censored on the date of the last adequate tumor assessment.

  • Overall Survival (OS) [ Time Frame: From date of randomization to date of death from any cause whichever comes first, assessed up to 24 months ] [ Designated as safety issue: No ]
    OS is defined as the time from the date of randomization to the date of death from any cause. If a patient is not known to have died at the date of analysis cut-off, the OS will be censored at the last date of contact.

  • Safety (type, frequency and severity of adverse events, and laboratory values) [ Time Frame: Screening, Week 2, Week 4 and approximately every 4 weeks during treatment period (approximately 6-9 months) ] [ Designated as safety issue: Yes ]
    The type, frequency and severity of adverse events, laboratory values, and Electrocardiograms (ECGs) experienced by patients will be assessed according to Common Terminology Criteria for Adverse Events

  • Eastern Cooperative Oncology Group (ECOG) Performance Status (scales and criteria used by doctors and researchers to assess how a patient's disease is progressing and assess how the disease affects the daily living abilities of the patient.) [ Time Frame: Screening, Every 4 weeks during treatment period, and every 8 weeks during follow-up (approximately 9-12 months) ] [ Designated as safety issue: No ]
    The time to worsening of ECOG performance status will be measured.


Estimated Enrollment: 150
Study Start Date: April 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fulvestrant + Dovitinib active
Fulvestrant in combination with the study drug Dovitinib. Fulvestrant (in solution) will be injected intramuscularly at a dose of 500 mg once on Week 1 Day 1, Week 3 Day 1 and Week 5 Day 1 and subsequently once every 4 weeks on Day 1 of the week. In addition, active Dovitinib (in tablet form) will be taken orally at a dose of 500 mg (i.e., 5 x 100mg tablets) on a 5 days on/2 days off dosing schedule (i.e patients will take Dovitinib on Day 1 through Day 5, and will take no medication on Day 6 and Day 7 "rest days").
Drug: Dovitinib
Active Dovitinib (in tablet form) will be taken orally at a dose of 500 mg (i.e., 5 x 100mg tablets) on a 5 days on/2 days off dosing schedule (i.e patients will take active Dovitinib on Day 1 through Day 5, and will take no medication on Day 6 and Day 7 "rest days").
Placebo Comparator: Fulvestrant + Dovitinib placebo
Fulvestrant in combination with a placebo matching Dovitinib. Fulvestrant (in solution) will be injected intramuscularly at a dose of 500 mg once on Week 1 Day 1, Week 3 Day 1 and Week 5 Day 1 and subsequently once every 4 weeks on Day 1 of the week. Placebo Dovitinib (in tablet form) will be taken orally at a dose of 500 mg (i.e., 5 x 100mg tablets) on a 5 days on/2 days off dosing schedule (i.e patients will take placebo Dovitinib on Day 1 through Day 5, and will take no medication on Day 6 and Day 7 "rest days").
Drug: Fulvestrant
Fulvestrant (in solution) will be injected intramuscularly at a dose of 500 mg once on Week 1 Day 1, Week 3 Day 1 and Week 5 Day 1 and subsequently once every 4 weeks on Day 1 of the week.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Evidence of CNS or leptomeningeal metastases
  2. Previous treatment with fulvestrant
  3. Previous chemotherapy for locally advanced or metastatic breast cancer
  4. Cirrhosis or chronic active/persistent hepatitis

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01528345

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Show 94 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01528345     History of Changes
Other Study ID Numbers: CTKI258A2210, 2011-001230-42
Study First Received: January 31, 2012
Last Updated: March 20, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Austria: Federal Ministry for Health and Women
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: Ministry of Health
Egypt: Ministry of Health and Population
France: Agence française de sécurité sanitaire des produits de santé (Afssaps)
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Italy: Italian Pharmaceutical Agency (AIFA)
Netherlands: Medicines Evaluation Board (MEB)
Peru: National Health Institute
Poland: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
South Africa: Department of Health
Spain: Medicines and Health Products Agency (AEMPS)
Taiwan: Department of Health

Keywords provided by Novartis:
Breast Cancer
HER2-, HR+
post-menopausal
Locally advanced or metastatic Breast Cancer (HER2-, HR+)

Additional relevant MeSH terms:
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Estradiol
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Estrogen Antagonists
Estrogen Receptor Modulators
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Estrogens

ClinicalTrials.gov processed this record on July 28, 2014