Trial · NCT01492101

The BEACON Study (Breast Cancer Outcomes With NKTR-102)

NCT01492101, Phase 3, Completed, Nektar Therapeutics; results first posted 2021-06-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The BEACON Study (Breast Cancer Outcomes With NKTR-102). Trials, record NCT01492101. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01492101

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Trial

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

Title: The BEACON Study (Breast Cancer Outcomes With NKTR-102)
NCT number: NCT01492101
Status: Completed
Phases: Phase 3
Enrollment: 852 participants, actual
Lead sponsor: Nektar Therapeutics
Conditions: Locally Recurrent Breast Cancer, Metastatic Breast Cancer
Interventions: NKTR-102, Treatment of Physician's Choice (TPC)
First posted: 2011-12-14
Last updated: 2021-06-01
Results first posted: 2021-06-01

Source ClinicalTrials.gov

Registered outcomes13

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

List	Outcome	Time frame	Description
Primary	Kaplan-Meier Estimate of Overall Survival: Intention to Treat (ITT) Population	36 Months	Duration of OS was defined as the time from the date of randomisation to the date of death due to any cause. Subjects were followed until their date of death, loss to follow-up, withdrawal of consent for further follow-up for survival, or final database closure. OS was determined using the ITT population which included all subjects randomized into 1 of the 2 treatment arms. Subjects who were lost-to-follow-up or were not known to have died were censored at last date they were shown to be alive. Subjects who did not have any follow-up since the date of randomization were censored at the date of randomization.
Secondary	Kaplan-Meier Estimate of Progression-Free Survival (PFS): ITT Population	Up to 38 months.	PFS was defined as the time from the date of randomization to the earliest date of disease progression (assessed by the investigator according to RECIST version 1.1) or death due to any cause. PFS was determined using the ITT population which included all subjects randomized into 1 of the 2 treatment arms. For subjects whose disease did not progress or who did not die, the PFS time was censored at the time of the last tumor assessment that demonstrated lack of disease progression. For subjects who received new anti-cancer therapy, the PFS time was censored at the start of the new anti-cancer therapy.
Secondary	Clinical Benefit Rate (CBR): ITT Population	Up to 38 months.	CBR was defined as the proportion of subjects with a CR, PR, or stable disease (SD) for at least 6 months (≥ 182 days).
Secondary	Duration of Response (DOR): Efficacy Evaluable Population	Up to 38 months.	DOR was defined as the time from first documented CR or PR until the earliest evidence of disease progression or death from any cause. Subjects who were alive without documented disease progression per RECIST version 1.1 were censored at the date of last tumor assessment without disease progression or start of new anti-cancer therapy for the study disease.
Secondary	Incidence of Dose Reductions: Safety Population	Up to 38 months.	Proportion of subjects who had a reduction in dose.
Secondary	Quality of Life Questionnaire-Core 30 (QLQ-C30) Individual Scale, Overall Score: ITT Population	Up to 39 months	The QLQ-C30 is composed of 5 multi-item functional scales (physical, role, social, emotional and cognitive functioning), a global health status/QoL scale, 3 symptom scales (fatigue, nausea/vomiting, and pain), and 6 single items (financial impact, appetite loss, diarrhoea, constipation, insomnia and dyspnoea). Most items are scaled 1 to 4 (1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much) except the items contributing to the global health status/QoL, which are 7-point questions (1 = very poor to 7 = excellent). Raw scores were transformed using a linear transformation to standardize the results so that scores range from 0 to 100. n=number of subjects who completed each individual scale. Note that for scores measuring function, a higher score represented a higher "better" level of functioning, while for scores measuring symptoms, a higher score represented a lower "worse" level of symptoms.
Secondary	QLQ-C30 Individual Scale, Change Over Time: ITT Population	From Baseline to Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56.	The QLQ-C30 is composed of 5 multi-item functional scales (physical, role, social, emotional and cognitive functioning), a global health status/QoL scale, 3 symptom scales (fatigue, nausea/vomiting, and pain), and 6 single items (financial impact, appetite loss, diarrhea, constipation, insomnia and dyspnea). Most items are scaled 1 to 4 (1 = not at all, 2 = a little, 3 = quite a bit, 4 = very much) except the items contributing to the global health status/QoL, which are 7-point questions (from 1 = very poor to 7 = excellent). Raw scores were transformed using a linear transformation to standardize the results so that scores range from 0 to 100. n=number of subjects who completed each individual scale. Note that for scores measuring function, a higher score represented a higher "better" level of functioning, while for scores measuring symptoms, a higher score represented a lower "worse" level of symptoms.
Secondary	Quality of Life Questionnaire-breast Cancer-specific Module (BR23) Score Value: ITT Population	Baseline	The QLQ-BR23 incorporates 5 multi-item scales to assess systemic therapy side effects, arm symptoms, breast symptoms, body image and sexual functioning, and 3 single items to assess sexual enjoyment, upset by hair loss and future perspective. Most items were scaled one to four except the items contributing to the global health status/QoL, which were seven-point questions. Raw scores were transformed using a linear transformation to standardize the results so that scores ranged from 0-100. Note that for scores measuring function, a higher score represented a higher "better" level of functioning, while for scores measuring symptoms, a higher score represented a lower "worse" level of symptoms.
Secondary	BR23 Score Change Over Time: ITT Population	Up to 38 months.	The QLQ-BR23 incorporates 5 multi-item scales to assess systemic therapy side effects, arm symptoms, breast symptoms, body image and sexual functioning, and 3 single items assess sexual enjoyment, upset by hair loss and future perspective. Most items were scaled one to four except the items contributing to the global health status/QoL, which were seven-point questions. Raw scores were transformed using a linear transformation to standardize the results so that scores ranged from 0-100. Note that for scores measuring function, a higher score represented a higher "better" level of functioning, while for scores measuring symptoms, a higher score represented a lower "worse" level of symptoms.
Secondary	Population Mean ± Standard Deviation (SD) Area Under the Concentration-Time Curve (AUC) for NKTR-102 and Metabolites After Multiple Administration of 145 mg/m^2 NKTR-102 [25]	Up to 38 months.	Plasma concentrations of NKTR-102 and its major metabolites irinotecan, SN38, SN38G, and APC were measured using validated analytical methods. The population pharmacokinetic (PK) model-derived mean AUC values were computed by integration from t = 0 (start of first dose) to 21 days after the last dose. Integration was implemented using a separate compartment defined as the amount of drug or metabolite in the central compartment divided by the model-estimated volume of distribution.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Kaplan-Meier Estimate of Overall Survival: Intention to Treat (ITT) Population	36 Months		Months	MEDIAN
SECONDARY	Kaplan-Meier Estimate of Progression-Free Survival (PFS): ITT Population	Up to 38 months.		Months	MEDIAN
SECONDARY	Clinical Benefit Rate (CBR): ITT Population	Up to 38 months.		percentage of subjects	NUMBER
SECONDARY	Duration of Response (DOR): Efficacy Evaluable Population	Up to 38 months.	The population analyzed for this outcome measure solely comprised of patients who achieved CR or PR per RECIST.	Months	MEDIAN
SECONDARY	Incidence of Dose Reductions: Safety Population	Up to 38 months.		percentage of subjects	NUMBER
SECONDARY	Quality of Life Questionnaire-Core 30 (QLQ-C30) Individual Scale, Overall Score: ITT Population	Up to 39 months	429 (ITT Population) 423 (ITT Population)	units on a scale	MEAN
SECONDARY	QLQ-C30 Individual Scale, Change Over Time: ITT Population	From Baseline to Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56.	429 (ITT Population) 423 (ITT Population)	units on a scale	MEAN
SECONDARY	Quality of Life Questionnaire-breast Cancer-specific Module (BR23) Score Value: ITT Population	Baseline	429 (ITT Population) 423 (ITT Population)	units on a scale	MEAN
SECONDARY	BR23 Score Change Over Time: ITT Population	Up to 38 months.	429 (ITT Population) 423 (ITT Population)	units on a scale	MEAN
SECONDARY	Population Mean ± Standard Deviation (SD) Area Under the Concentration-Time Curve (AUC) for NKTR-102 and Metabolites After Multiple Administration of 145 mg/m^2 NKTR-102 [25]	Up to 38 months.		μg·h/mL	MEAN

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group391

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

Outcome	Group	Value	Spread	Units
Kaplan-Meier Estimate of Overall Survival: Intention to Treat (ITT) Population	NKTR-102	12.4	95% Confidence Interval 11.0 to 13.6	Months
Kaplan-Meier Estimate of Overall Survival: Intention to Treat (ITT) Population	Physician's Treatment of Choice	10.3	95% Confidence Interval 9.0 to 11.3	Months
Kaplan-Meier Estimate of Progression-Free Survival (PFS): ITT Population	NKTR-102	2.4	95% Confidence Interval 2.1 to 3.5	Months
Kaplan-Meier Estimate of Progression-Free Survival (PFS): ITT Population	Physician's Treatment of Choice	2.8	95% Confidence Interval 2.1 to 3.5	Months
Clinical Benefit Rate (CBR): ITT Population	NKTR-102	20.5	95% Confidence Interval 16.8 to 24.6	percentage of subjects
Clinical Benefit Rate (CBR): ITT Population	Physician's Treatment of Choice	19.6	95% Confidence Interval 15.9 to 23.7	percentage of subjects
Duration of Response (DOR): Efficacy Evaluable Population	NKTR-102	3.9	95% Confidence Interval 3.5 to 5.1	Months
Duration of Response (DOR): Efficacy Evaluable Population	Physician's Treatment of Choice	3.7	95% Confidence Interval 2.1 to 3.9	Months
Incidence of Dose Reductions: Safety Population	NKTR-102	27.5		percentage of subjects
Incidence of Dose Reductions: Safety Population	Physician's Treatment of Choice	28.3		percentage of subjects

1 to 10 of 391Source ClinicalTrials.gov

See all 391 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	NKTR-102	429
Overall Study	STARTED	Physician's Treatment of Choice	423
Overall Study	COMPLETED	NKTR-102	92
Overall Study	COMPLETED	Physician's Treatment of Choice	81
Overall Study	NOT COMPLETED	NKTR-102	337
Overall Study	NOT COMPLETED	Physician's Treatment of Choice	342

Source ClinicalTrials.gov

Adverse events420

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	Weight decreased	Investigations	NKTR-102	57	425	65
other	Weight decreased	Investigations	Physician's Treatment of Choice	24	406	25
other	Neutrophil count decreased	Investigations	NKTR-102	26	425	41
other	Neutrophil count decreased	Investigations	Physician's Treatment of Choice	50	406	126
other	Aspartate aminotransferase increased	Investigations	NKTR-102	23	425	24
other	Aspartate aminotransferase increased	Investigations	Physician's Treatment of Choice	29	406	31
other	Dyspnoea	Respiratory, thoracic and mediastinal disorders	NKTR-102	58	425	68
other	Dyspnoea	Respiratory, thoracic and mediastinal disorders	Physician's Treatment of Choice	70	406	87
other	Cough	Respiratory, thoracic and mediastinal disorders	NKTR-102	59	425	64
other	Cough	Respiratory, thoracic and mediastinal disorders	Physician's Treatment of Choice	52	406	55

1 to 10 of 420Source ClinicalTrials.gov

See all 420 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	NKTR-102	323	425
Total, all-cause mortality	Physician's Treatment of Choice	322	406
Total, other adverse events	NKTR-102	417	425
Total, other adverse events	Physician's Treatment of Choice	404	406
Total, serious adverse events	NKTR-102	128	425
Total, serious adverse events	Physician's Treatment of Choice	129	406

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26482278	DERIVED	PubMed
28360015	DERIVED	PubMed
28612225	DERIVED	PubMed
30957581	DERIVED	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
NKTR-102 vs Physician's Treatment of Choice: deaths from any cause	Trial comparisons
NKTR-102 vs Physician's Treatment of Choice: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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