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History of Changes for Study: NCT01528345
Trial Evaluating TKI258 Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer
Latest version (submitted May 26, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 7, 2012 None (earliest Version on record)
2 February 9, 2012 Arms and Interventions, Outcome Measures, Study Identification, Contacts/Locations, Sponsor/Collaborators and Study Status
3 March 1, 2012 Study Status and Contacts/Locations
4 March 7, 2012 Sponsor/Collaborators and Study Status
5 April 25, 2012 Recruitment Status, Study Status, Contacts/Locations and Study Design
6 June 20, 2012 Study Status and Contacts/Locations
7 July 19, 2012 Contacts/Locations and Study Status
8 October 8, 2012 Contacts/Locations and Study Status
9 April 9, 2013 Contacts/Locations and Study Status
10 October 18, 2013 Contacts/Locations and Study Status
11 March 12, 2014 Contacts/Locations and Study Status
12 March 17, 2014 Contacts/Locations and Study Status
13 March 20, 2014 Contacts/Locations and Study Status
14 November 5, 2014 Contacts/Locations and Study Status
15 May 15, 2015 Study Status
16 June 19, 2015 Recruitment Status, Contacts/Locations, Study Status and Study Design
17 May 26, 2016 Recruitment Status, Study Status, Outcome Measures, Arms and Interventions, Results, Contacts/Locations, Eligibility and Oversight
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Study NCT01528345
Submitted Date:  February 7, 2012 (v1)
Open or close this module Study Identification
Unique Protocol ID: CTKI258A2210
Brief Title: Trial Evaluating TKI258 Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer
Official Title: A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase II Trial Evaluating the Safety and Efficacy of TKI258 Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer That Have Evidence of Disease Progression on or After Prior Endocrine Therapy
Secondary IDs: 2011-001230-42 [EudraCT Number]
Open or close this module Study Status
Record Verification: February 2012
Overall Status: Not yet recruiting
Study Start: March 2012
Primary Completion: February 2014 [Anticipated]
Study Completion: February 2014 [Anticipated]
First Submitted: January 31, 2012
First Submitted that
Met QC Criteria:		 February 7, 2012
First Posted: February 8, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:		 February 7, 2012
Last Update Posted: February 8, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Novartis Pharmaceuticals
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary:

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.
Detailed Description:
Open or close this module Conditions
Conditions: Metastatic Breast Cancer
Keywords: Breast Cancer
HER2-, HR+
post-menopausal
Locally advanced or metastatic Breast Cancer (HER2-, HR+)
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 150 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Fulvestrant + TKI258 active

Fulvestrant in combination with the study drug TKI258. 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 TKI258 (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 TKI258 on Day 1 through Day 5, and will take no medication on Day 6 and Day 7 "rest days").

 Drug: TKI258 (Dovitinib)
Active TKI258 (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 TKI258 on Day 1 through Day 5, and will take no medication on Day 6 and Day 7 "rest days").
Placebo Comparator: Fulvestrant + TKI258 placebo

Fulvestrant in combination with a placebo matching TKI258. 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 TKI258 (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 TKI258 on Day 1 through Day 5, and will take no medication on Day 6 and Day 7 "rest days").

 Device: 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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Time to Progression Free Survival (PFS)
[ Time Frame: From date of randomization to disease progression or death (up to 24 months) ]

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:
1. Overall Response Rate (ORR)
[ Time Frame: Every 8 weeks assessed up to 24 months ]

ORR is defined as the percentage of patients with a best overall response of Complete Response (CR) or Partial Response (PR) as per RECIST
2. 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 ]

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.
3. Overall Survival (OS)
[ Time Frame: From date of randomization to date of death from any cause whichever comes first, assessed up to 24 months ]

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.
4. 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) ]

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
5. 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) ]

The time to worsening of ECOG performance status will be measured.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Female
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Novartis Pharmaceuticals
Telephone: +1-862-778-8300
Study Officials: Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
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