Trial · NCT01560416

Fulvestrant With or Without Ganetespib in HR+ Breast Cancer

NCT01560416, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2019-01-03

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Fulvestrant With or Without Ganetespib in HR+ Breast Cancer. Trials, record NCT01560416. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01560416

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Fulvestrant With or Without Ganetespib in HR+ Breast Cancer
NCT number: NCT01560416
Status: Completed
Phases: Phase 2
Enrollment: 50 participants, actual
Lead sponsor: Dana-Farber Cancer Institute
Conditions: Breast Cancer
Interventions: Fulvestrant, Ganetespib
First posted: 2012-03-22
Last updated: 2026-03-03
Results first posted: 2019-01-03

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression-Free Survival (PFS)	Disease was assessed radiographically every 2 cycles for year 1 and every 2-4 cycles longer-term. Participants in this study cohort were followed for survival up to 4 years from treatment end.	PFS based on Kaplan-Meier is defined as the time from study entry to the earliest documentation of disease progression (PD) or death. Participants alive without evidence of PD are censored at the date of last disease assessment. Participants who receive non-protocol anti-cancer therapy before disease progression are censored at time of last disease assessment.
Secondary	Grade 3-4 Toxicity Rate	AEs were assessed every cycle on treatment (weeks 2-3 on cycle 1). Median treatment duration was 4 cycles/~4 months on each arm. Maximum treatment duration was 41 cycles (Arm A) and 42 cycles (Arm B) which approximates 38 months.	All grade 3-4 adverse events (AE) with treatment attribution of possibly, probably or definite based on NCI Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4) as reported on case report forms were counted to calculate the percentage of participants experiencing at least one treatment-related grade 3 or 4 AE of any type on treatment.
Secondary	Objective Response Rate (ORR)	Disease was assessed radiographically every 2 cycles for year 1 and every 2-4 cycles thereafter on treatment. Maximum treatment duration was 41 cycles (Arm A) and 42 cycles (Arm B) which approximates 38 months.	ORR was defined as the percentage of participants with measurable disease at baseline achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Secondary	Clinical Benefit Rate (CBR)	Disease was assessed radiographically every 2 cycles for year 1 and every 2-4 cycles thereafter on treatment. Maximum treatment duration was 41 cycles (Arm A) and 42 cycles (Arm B) which approximates 38 months.	CBR was defined as the percentage of participants with measurable disease at baseline achieving complete response (CR), partial response (PR), or stable disease (SD) for 24 weeks or longer based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PD is at least a 20% increase in sum LD of target lesions (smallest sum LD reference), new lesions, and/or unequivocal progression of existing non-target lesions. Stable disease (SD) is defined as any condition not meeting the above criteria. SD needed to be a minimum 24 weeks in duration.
Secondary	Overall Survival (OS)	Participants were followed long-term for survival every 3 months from the end of treatment until death, lost to follow-up or up to 4 years from treatment end. Median survival follow-up was 28 months for the study cohort.	OS based on Kaplan-Meier is defined as the time from study entry to death or date last known alive or censored at date last known alive.

Source ClinicalTrials.gov

Outcomes5

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)	Disease was assessed radiographically every 2 cycles for year 1 and every 2-4 cycles longer-term. Participants in this study cohort were followed for survival up to 4 years from treatment end.		months	MEAN
SECONDARY	Grade 3-4 Toxicity Rate	AEs were assessed every cycle on treatment (weeks 2-3 on cycle 1). Median treatment duration was 4 cycles/~4 months on each arm. Maximum treatment duration was 41 cycles (Arm A) and 42 cycles (Arm B) which approximates 38 months.		percentage of participants	NUMBER
SECONDARY	Objective Response Rate (ORR)	Disease was assessed radiographically every 2 cycles for year 1 and every 2-4 cycles thereafter on treatment. Maximum treatment duration was 41 cycles (Arm A) and 42 cycles (Arm B) which approximates 38 months.	The analysis dataset is comprised of all enrolled participants.	percentage of participants	NUMBER
SECONDARY	Clinical Benefit Rate (CBR)	Disease was assessed radiographically every 2 cycles for year 1 and every 2-4 cycles thereafter on treatment. Maximum treatment duration was 41 cycles (Arm A) and 42 cycles (Arm B) which approximates 38 months.	The analysis dataset is comprised of all enrolled participants.	percentage of participants	NUMBER
SECONDARY	Overall Survival (OS)	Participants were followed long-term for survival every 3 months from the end of treatment until death, lost to follow-up or up to 4 years from treatment end. Median survival follow-up was 28 months for the study cohort.	The analysis dataset is comprised of all enrolled participants.	months	MEDIAN

Source ClinicalTrials.gov

Results by group11

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Progression-Free Survival (PFS)	ARM A - Fulvestrant	3.7	95% Confidence Interval 1.0 to 12.0	months
Progression-Free Survival (PFS)	Arm B - Fulvestrant+Ganetespib	3.6	95% Confidence Interval 2.0 to 7.5	months
Grade 3-4 Toxicity Rate	ARM A - Fulvestrant	100		percentage of participants
Grade 3-4 Toxicity Rate	Arm B - Fulvestrant+Ganetespib	100		percentage of participants
Grade 3-4 Toxicity Rate	Arm A - Crossover Fulvestrant+Ganetespib	100		percentage of participants
Objective Response Rate (ORR)	ARM A - Fulvestrant	20.0	95% Confidence Interval 4.3 to 48.1	percentage of participants
Objective Response Rate (ORR)	Arm B - Fulvestrant+Ganetespib	14.3	95% Confidence Interval 4.8 to 30.3	percentage of participants
Clinical Benefit Rate (CBR)	ARM A - Fulvestrant	33.3	95% Confidence Interval 11.8 to 61.6	percentage of participants
Clinical Benefit Rate (CBR)	Arm B - Fulvestrant+Ganetespib	34.3	95% Confidence Interval 19.1 to 52.2	percentage of participants
Overall Survival (OS)	ARM A - Fulvestrant	25.9	95% Confidence Interval 23.1 to NA	months

1 to 10 of 11Source ClinicalTrials.gov

See all 11 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Randomized Phase	STARTED	ARM A - Fulvestrant	15
Randomized Phase	STARTED	Arm B - Fulvestrant+Ganetespib	35
Randomized Phase	COMPLETED	ARM A - Fulvestrant	8
Randomized Phase	COMPLETED	Arm B - Fulvestrant+Ganetespib	35
Randomized Phase	NOT COMPLETED	ARM A - Fulvestrant	7
Randomized Phase	NOT COMPLETED	Arm B - Fulvestrant+Ganetespib	0
Crossover Phase	STARTED	ARM A - Fulvestrant	7
Crossover Phase	STARTED	Arm B - Fulvestrant+Ganetespib	0
Crossover Phase	COMPLETED	ARM A - Fulvestrant	7
Crossover Phase	COMPLETED	Arm B - Fulvestrant+Ganetespib	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events153

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	Diarrhea	Gastrointestinal disorders	ARM A - Fulvestrant	1	15	1
other	Diarrhea	Gastrointestinal disorders	Arm B - Fulvestrant+Ganetespib	34	35	34
other	Diarrhea	Gastrointestinal disorders	Arm A - Crossover Fulvestrant+Ganetespib	6	7	6
other	fatigue	General disorders	ARM A - Fulvestrant	9	15	9
other	fatigue	General disorders	Arm B - Fulvestrant+Ganetespib	23	35	23
other	fatigue	General disorders	Arm A - Crossover Fulvestrant+Ganetespib	2	7	2
other	nausea	Gastrointestinal disorders	ARM A - Fulvestrant	6	15	6
other	nausea	Gastrointestinal disorders	Arm B - Fulvestrant+Ganetespib	22	35	22
other	nausea	Gastrointestinal disorders	Arm A - Crossover Fulvestrant+Ganetespib	1	7	1
other	back pain	Musculoskeletal and connective tissue disorders	ARM A - Fulvestrant	2	15	2

1 to 10 of 153Source ClinicalTrials.gov

See all 153 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ARM A - Fulvestrant	11	15
Total, all-cause mortality	Arm B - Fulvestrant+Ganetespib	15	35
Total, all-cause mortality	Arm A - Crossover Fulvestrant+Ganetespib	6	7
Total, other adverse events	ARM A - Fulvestrant	15	15
Total, other adverse events	Arm B - Fulvestrant+Ganetespib	35	35
Total, other adverse events	Arm A - Crossover Fulvestrant+Ganetespib	7	7
Total, serious adverse events	ARM A - Fulvestrant	2	15
Total, serious adverse events	Arm B - Fulvestrant+Ganetespib	11	35
Total, serious adverse events	Arm A - Crossover Fulvestrant+Ganetespib	0	7

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
42873573	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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone 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/NCT01560416

GET https://conductscience.org/api/trials/v1/NCT01560416/events?page=2

API reference For AI assistants