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Metastatic Breast CancerPhase 2NCT01528345

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

A Phase 2 study testing Dovitinib and Fulvestrant in people with Metastatic Breast Cancer, run by Novartis Pharmaceuticals at 67 sites in 15 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Dovitinib and Fulvestrant
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
97 participants
Where
67 sitesin 15 countries
Study dates
Apr 2012to Apr 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

67 sites in 15 countries.

67 sites in 15 countries

United States18 sites

  • Ironwood Cancer and Research Centers SC

    Chandler, Arizona, 85224

  • City of Hope National Medical Center COH 3

    Duarte, California, 91010-3000

  • Duke University Medical Center Duke (SC)

    Durham, North Carolina, 27710

  • Virginia Cancer Specialists, PC Dept.ofFairfax SC

    Fairfax, Virginia, 22031

  • Highlands Oncology Group Dept of Highlands Oncology Grp

    Fayetteville, Arkansas, 72703

  • Indiana University Health Goshen Center for Cancer SC

    Goshen, Indiana, 46526

  • Cancer Centers of the Carolinas Dept. of CC of the Carolinas

    Greenville, South Carolina, 29605

  • University of California San Diego - Moores Cancer Center Moores UCSD Cancer Ctr. SC-1

    La Jolla, California, 92093-0658

  • ProHealth Care

    Lake Success, New York, 11042

  • Saint Barnabas Medical Center CancerCenter of Saint Barnabas

    Livingston, New Jersey, 07039

  • Cedars Sinai Medical Center Samuel Oschin Cancer Center

    Los Angeles, California, 90048

  • Nebraska Methodist Hospital Estabrook Cancer Center

    Omaha, Nebraska, 68114

  • Oncology Specialists, SC Lutheran General Advanced Care

    Park Ridge, Illinois, 60068-0736

  • Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2)

    San Antonio, Texas, 78229

  • Medical Oncology Associates, PS

    Spokane, Washington, 99208

  • H. Lee Moffitt Cancer Center & Research Institute H. Lee Moffitt SC

    Tampa, Florida, 33612

  • New York Oncology Hematology, P.C. Dept. of New York Oncology. PC

    Troy, New York, 12180

  • Wenatchee Valley Medical Center Wenatchee Valley

    Wenatchee, Washington, 98801

Other trials in United States

Hungary7 sites

  • Novartis Investigative Site

    Budapest, 1134

  • Novartis Investigative Site

    Budapest, 1145

  • Novartis Investigative Site

    Budapest, H-1083

  • Novartis Investigative Site

    Debrecen, 4032

  • Novartis Investigative Site

    Győr, Hungary, H-9023

  • Novartis Investigative Site

    Szeged, H-6720

  • Novartis Investigative Site

    Szolnok, H-5000

Other trials in Hungary

France6 sites

  • Novartis Investigative Site

    Besançon, 25030

  • Novartis Investigative Site

    Bordeaux, 33076

  • Novartis Investigative Site

    Lille, 59020

  • Novartis Investigative Site

    Saint-Herblain Cédex, 44805

  • Novartis Investigative Site

    Thonon-les-Bains, 74203

  • Novartis Investigative Site

    Villejuif, 94805

Other trials in France

Brazil5 sites

  • Novartis Investigative Site

    Londrina, Paraná, 86015-520

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 40170-110

  • Novartis Investigative Site

    São José do Rio Preto, São Paulo, 15090-000

  • Novartis Investigative Site

    São Paulo, São Paulo, 01317-002

Other trials in Brazil

Poland5 sites

  • Novartis Investigative Site

    Poznan, 60-569

  • Novartis Investigative Site

    Rzeszów, 35-021

  • Novartis Investigative Site

    Warsaw, 02-781

  • Novartis Investigative Site

    Warsaw, 03-291

  • Novartis Investigative Site

    Warsaw, 04-125

Other trials in Poland

Argentina4 sites

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1050AAK

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5006IKK

  • Novartis Investigative Site

    Rio Negro, Viedma, 8500

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province, T4000IAK

Other trials in Argentina

Spain4 sites

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035

  • Novartis Investigative Site

    Madrid, Madrid, 28007

  • Novartis Investigative Site

    Toledo, Castille-La Mancha, 45071

  • Novartis Investigative Site

    Valencia, Valencia, 46010

Other trials in Spain

Italy3 sites

  • Novartis Investigative Site

    Parma, PR, 43100

  • Novartis Investigative Site

    Province of Macerata, MC, 62100

  • Novartis Investigative Site

    Sondrio, SO, 23100

Other trials in Italy

South Africa3 sites

  • Novartis Investigative Site

    Cape Town, 7500

  • Novartis Investigative Site

    Parktown, 2193

  • Novartis Investigative Site

    Port Elizabeth, 6045

Other trials in South Africa

Taiwan3 sites

  • Novartis Investigative Site

    Niaosong Township, Taiwan, 83301

  • Novartis Investigative Site

    Taichung, Taichung, 407

  • Novartis Investigative Site

    Taipei, Taiwan, 10048

Other trials in Taiwan

Austria2 sites

  • Novartis Investigative Site

    Salzburg, 5020

  • Novartis Investigative Site

    Vienna, 1090

Other trials in Austria

Belgium2 sites

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Wilrijk, 2610

Other trials in Belgium

Netherlands2 sites

  • Novartis Investigative Site

    Maastricht, 6229 HX

  • Novartis Investigative Site

    Rotterdam, 3075 EA

Other trials in Netherlands

Russia2 sites

  • Novartis Investigative Site

    Ryazan, Russia, 390011

  • Novartis Investigative Site

    Saint Petersburg, 197758

Other trials in Russia

Peru1 site

  • Novartis Investigative Site

    Surquillo, Lima region, 34

Other trials in Peru

About this study

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

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.

Being tested
Dovitinib, Fulvestrant, Dovitinib Placebo
Keywords
Breast Cancer, HER2-, HR+, post-menopausal, Locally advanced or metastatic Breast Cancer (HER2-, HR+)
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DovitinibDrug

    Also called TKI258

    Active Dovitinib (in tablet form) taken orally at a dose of 500 mg (i.e., 5 x 100mg tablets) on a 5 days on/2 days off dosing schedule

  • FulvestrantDrug

    Fulvestrant (in solution) 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.

  • Dovitinib PlaceboDrug

    Dovitinib Placebo (in tablet form) taken orally at a dose of 500 mg (i.e., 5 x 100mg tablets) on a 5 days on/2 days off dosing schedule

Study groups in NCT01528345
Study groupRoleWhat they receive
Fulvestrant + Dovitinib activeExperimentalFulvestrant in combination with the study drug Dovitinib.
Receives: Drug: Dovitinib; Drug: Fulvestrant
Fulvestrant + Dovitinib placeboPlacebo comparatorFulvestrant in combination with a placebo matching Dovitinib.
Receives: Drug: Fulvestrant; Drug: Dovitinib Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS) Based on Local Investigator Assessment

    PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause and was assessed based on RECIST v1.1. Responses include: Complete Response: Disappearance of all non-nodal target lesions; Partial Response: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; Progressive Disease: At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline; Stable Disease: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; Unknown (UNK) Progression has not been documented and one or more target lesions have not been assessed or have been assessed using a different method than baseline.

    Measured: Every 8 weeks assessed up to 34 months

Secondary outcomes (5)

  1. Overall Response Rate (ORR)

    ORR was defined as the percentage of patients with a best overall response of Complete Response (CR) or Partial Response (PR) as per RECIST v1.1. Responses include: Complete Response: Disappearance of all non-nodal target lesions; Partial Response: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; Progressive Disease: At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline; Stable Disease: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; Unknown (UNK) Progression has not been documented and one or more target lesions have not been assessed or have been assessed using a different method than baseline.

    Measured: Every 8 weeks assessed up to 34 months

  2. Duration of Response (DOR)

    DOR was 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.

    Measured: From date of first documented efficacy response (CR or PR) to time of documented progression (PD) whichever comes first, assessed up to 24 months

  3. Overall Survival (OS) Using Kaplan- Meier Method

    OS was 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.

    Measured: From date of randomization to date of death from any cause whichever comes first, assessed up to 34 months

  4. Number of Participants With Adverse Events as a Measure of Safety

    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.

    The study enrollment was terminated early due to challenges in enrolling patients with FGF amplified status. See safety section for safety details.

    Measured: Screening, Week 2, Week 4 and approximately every 4 weeks during treatment period (approximately 34 months)

  5. Time to Worsening of ECOG Performance Status

    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.)

    Measured: Screening, Every 4 weeks during treatment period, and every 8 weeks during follow-up (approximately 9-12 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionApr 2015
  4. Study completionApr 2015

Why it stopped: Slow and low enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01528345
Sponsor's protocol ID
CTKI258A2210
Other IDs
2011-001230-42
Status last verified
May 2016
First submitted
31 Jan 2012
Last updated
11 Jul 2016
Data monitoring committee
Yes

Publications

  • Musolino A, Campone M, Neven P, Denduluri N, Barrios CH, Cortes J, Blackwell K, Soliman H, Kahan Z, Bonnefoi H, Squires M, Zhang Y, Deudon S, Shi MM, Andre F. Phase II, randomized, placebo-controlled study of dovitinib in combination with fulvestrant in postmenopausal patients with HR+, HER2- breast cancer that had progressed during or after prior endocrine therapy. Breast Cancer Res. 2017 Feb 10;19(1):18. doi: 10.1186/s13058-017-0807-8.

    PubMed 28183331

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dovitinib and Fulvestrant in people with Metastatic Breast Cancer, run by Novartis Pharmaceuticals at 67 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States, Hungary, France, Brazil, Poland and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) Based on Local Investigator Assessment (time frame: Every 8 weeks assessed up to 34 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01528345, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2016.

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