Trial · NCT01528345
Trial Evaluating Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer
NCT01528345, Phase 2, Terminated, Novartis Pharmaceuticals; results first posted 2016-07-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial Evaluating Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer. Trials, record NCT01528345. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01528345
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial Evaluating Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer
- NCT number
- NCT01528345
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 97 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Metastatic Breast Cancer
- Interventions
- Dovitinib, Fulvestrant, Dovitinib Placebo
- First posted
- 2012-02-08
- Last updated
- 2016-07-11
- Other registries' IDs
- eudract:2011-001230-42
- Results first posted
- 2016-07-11
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) Based on Local Investigator Assessment | Every 8 weeks assessed up to 34 months | 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. |
| Secondary | Overall Response Rate (ORR) | Every 8 weeks assessed up to 34 months | 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. |
| Secondary | Duration of Response (DOR) | 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 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. |
| Secondary | Overall Survival (OS) Using Kaplan- Meier Method | From date of randomization to date of death from any cause whichever comes first, assessed up to 34 months | 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. |
| Secondary | Number of Participants With Adverse Events as a Measure of Safety | Screening, Week 2, Week 4 and approximately every 4 weeks during treatment period (approximately 34 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. The study enrollment was terminated early due to challenges in enrolling patients with FGF amplified status. See safety section for safety details. |
| Secondary | Time to Worsening of ECOG Performance Status | Screening, Every 4 weeks during treatment period, and every 8 weeks during follow-up (approximately 9-12 months) | 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.) |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) Based on Local Investigator Assessment | Every 8 weeks assessed up to 34 months | Full Analysis Set (FAS): Consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum to which they wereassigned at randomization. | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) | Every 8 weeks assessed up to 34 months | Full Analysis Set (FAS): Consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum to which they were assigned at randomization. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | From date of first documented efficacy response (CR or PR) to time of documented progression (PD) whichever comes first, assessed up to 24 months | This outcome measure was not analyzed as the study was terminated before duration of response could be analyzed. | ||
| SECONDARY | Overall Survival (OS) Using Kaplan- Meier Method | From date of randomization to date of death from any cause whichever comes first, assessed up to 34 months | Full Analysis Set (FAS): Consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum to which they were assigned at randomization. | Months | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events as a Measure of Safety | Screening, Week 2, Week 4 and approximately every 4 weeks during treatment period (approximately 34 months) | Safety Set: Consisted of all patients who received at least one dose of any compound of the study treatment (dovitinib +fulvestrant or placebo+fulvestrant). Patients were analyzed according to the actual study treatment received. Actual treatment received was defined as the treatment the patient received at the first day of study medication. | Participants | NUMBER |
| SECONDARY | Time to Worsening of ECOG Performance Status | Screening, Every 4 weeks during treatment period, and every 8 weeks during follow-up (approximately 9-12 months) | This outcome measure was not analyzed as the study was terminated before time to worsening ECOG performance could be analyzed. |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) Based on Local Investigator Assessment | Fulvestrant + Dovitinib Active | All patients (n: 30, 34) | 5.5 | 95% Confidence Interval 3.8 to 14.0 | Months |
| Progression Free Survival (PFS) Based on Local Investigator Assessment | Fulvestrant + Dovitinib Placebo | All patients (n: 30, 34) | 5.5 | 95% Confidence Interval 3.5 to 10.7 | Months |
| Progression Free Survival (PFS) Based on Local Investigator Assessment | Fulvestrant + Dovitinib Active | FGF amplified patients (n: 9, 9) | 10.9 | 95% Confidence Interval 3.5 to 16.5 | Months |
| Progression Free Survival (PFS) Based on Local Investigator Assessment | Fulvestrant + Dovitinib Placebo | FGF amplified patients (n: 9, 9) | 5.5 | 95% Confidence Interval 3.5 to 16.4 | Months |
| Progression Free Survival (PFS) Based on Local Investigator Assessment | Fulvestrant + Dovitinib Active | FGF non-amplified patients (n: 21, 25) | 5.5 | 95% Confidence Interval 3.8 to 16.8 | Months |
| Progression Free Survival (PFS) Based on Local Investigator Assessment | Fulvestrant + Dovitinib Placebo | FGF non-amplified patients (n: 21, 25) | 5.5 | 95% Confidence Interval 1.9 to 12.8 | Months |
| Overall Response Rate (ORR) | Fulvestrant + Dovitinib Active | All patients | 27.7 | 95% Confidence Interval 15.6 to 42.6 | Percentage of participants |
| Overall Response Rate (ORR) | Fulvestrant + Dovitinib Placebo | All patients | 10.0 | 95% Confidence Interval 3.3 to 21.8 | Percentage of participants |
| Overall Response Rate (ORR) | Fulvestrant + Dovitinib Active | FGF amplified patients | 20.0 | 95% Confidence Interval 4.3 to 48.1 | Percentage of participants |
| Overall Response Rate (ORR) | Fulvestrant + Dovitinib Placebo | FGF amplified patients | 12.5 | 95% Confidence Interval 1.6 to 38.3 | Percentage of participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fulvestrant + Dovitinib Active | 47 | |
| Overall Study | STARTED | Fulvestrant + Dovitinib Placebo | 50 | |
| Overall Study | COMPLETED | Fulvestrant + Dovitinib Active | 0 | |
| Overall Study | COMPLETED | Fulvestrant + Dovitinib Placebo | 0 | |
| Overall Study | NOT COMPLETED | Fulvestrant + Dovitinib Active | 47 | |
| Overall Study | NOT COMPLETED | Fulvestrant + Dovitinib Placebo | 50 |
Source ClinicalTrials.gov
Adverse events200
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Fulvestrant + Dovitinib Active | 9 | 47 | |
| other | ANAEMIA | Blood and lymphatic system disorders | Fulvestrant + Dovitinib Placebo | 4 | 50 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Fulvestrant + Dovitinib Active | 3 | 47 | |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Fulvestrant + Dovitinib Placebo | 0 | 50 | |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Fulvestrant + Dovitinib Active | 7 | 47 | |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Fulvestrant + Dovitinib Placebo | 0 | 50 | |
| other | EAR PAIN | Ear and labyrinth disorders | Fulvestrant + Dovitinib Active | 5 | 47 | |
| other | EAR PAIN | Ear and labyrinth disorders | Fulvestrant + Dovitinib Placebo | 0 | 50 | |
| other | VERTIGO | Ear and labyrinth disorders | Fulvestrant + Dovitinib Active | 6 | 47 | |
| other | VERTIGO | Ear and labyrinth disorders | Fulvestrant + Dovitinib Placebo | 0 | 50 |
1 to 10 of 200Source ClinicalTrials.gov
See all 200 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fulvestrant + Dovitinib Active | ||
| Total, all-cause mortality | Fulvestrant + Dovitinib Placebo | ||
| Total, other adverse events | Fulvestrant + Dovitinib Active | 47 | 47 |
| Total, other adverse events | Fulvestrant + Dovitinib Placebo | 45 | 50 |
| Total, serious adverse events | Fulvestrant + Dovitinib Active | 14 | 47 |
| Total, serious adverse events | Fulvestrant + Dovitinib Placebo | 10 | 50 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28183331 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Fulvestrant + Dovitinib Active vs Fulvestrant + Dovitinib Placebo: Number of Participants With Adverse Events as a Measure of Safety | Trial comparisons |
| Fulvestrant + Dovitinib Active vs Fulvestrant + Dovitinib Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01528345
GET https://conductscience.org/api/trials/v1/NCT01528345/events?page=2