Phase 3
N=852
The BEACON Study (Breast Cancer Outcomes With NKTR-102)
Locally Recurrent Breast Cancer · Metastatic Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01492101 ↗Enrolled (actual)
852
Serious AEs
30.9%
Results posted
Jun 2021
Primary outcome: Primary: Kaplan-Meier Estimate of Overall Survival: Intention to Treat (ITT) Population — 12.4; 10.3 Months — p== 0.0835
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- NKTR-102 (Drug); Treatment of Physician's Choice (TPC) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Nektar Therapeutics
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kaplan-Meier Estimate of Overall Survival: Intention to Treat (ITT) Population |
12.4; 10.3 | = 0.0835 |
| SECONDARY Kaplan-Meier Estimate of Progression-Free Survival (PFS): ITT Population |
2.4; 2.8 | = 0.3017 |
| SECONDARY Clinical Benefit Rate (CBR): ITT Population |
20.5; 19.6 | — |
| SECONDARY Duration of Response (DOR): Efficacy Evaluable Population |
3.9; 3.7 | — |
| SECONDARY Incidence of Dose Reductions: Safety Population |
27.5; 28.3 | — |
| SECONDARY Quality of Life Questionnaire-Core 30 (QLQ-C30) Individual Scale, Overall Score: ITT Population |
61.4; 58.0; 74.5; 72.3; 71.8; 67.3 | — |
| SECONDARY QLQ-C30 Individual Scale, Change Over Time: ITT Population |
-4.4; -4.7; -2.5; -5.6; -1.8; -6.6 | 0.635 |
| SECONDARY Quality of Life Questionnaire-breast Cancer-specific Module (BR23) Score Value: ITT Population |
69.5; 69.9; 14.1; 13.3; 36.1; 34.2 | — |
| SECONDARY BR23 Score Change Over Time: ITT Population |
-0.8; -2.2; -0.8; -2.3; 0.8; -4.7 | 0.5833 |
| 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] |
4619; 18.8; 5.32; 40.6; 4.0 | — |
| SECONDARY Population Mean ± SD Maximum Plasma Concentration (Cmax) for NKTR-102 and Metabolites After Multiple Administration of 145 mg/m^2 NKTR-102 [26] |
62701; 138; 4.45; 47.7; 7.3 | — |
| SECONDARY Population Mean ± SD Elimination Half-life (t½) for NKTR-102 After Multiple Administration of 145 mg/m^2 NKTR-102 [27] |
36.8 | — |
| SECONDARY Objective Response Rate (ORR): Efficacy Evaluable Population |
16.4; 17.0 | — |
Summary
The study is designed as an open-label, randomized, parallel, two arm, multicenter, international Phase 3 study in patients with recurrent or metastatic breast cancer previously treated with cytotoxic chemotherapy regimens.
The primary study objective is to compare overall survival of patients who receive NKTR-102 given once every 21 days to patients who receive treatment of Physician's Choice selected from a list of seven single-agent intravenous therapies.
Eligibility Criteria
Inclusion Criteria (major highlights):
- Patient is an adult female with histologically or cytologically confirmed carcinoma of the breast for whom single-agent cytotoxic chemotherapy is indicated
- Patient can have either measurable or non-measurable disease by RECIST.
- Patient has received prior therapy (administered in the neoadjuvant, adjuvant and/or metastatic setting) with an anthracycline, a taxane and capecitabine
- Patient has minimum of 2 and a maximum of 5 prior cytotoxic chemotherapy regimens with the last dose administered within 6 months. A minimum of two chemotherapy regimens had to be for locally recurrent and/or metastatic disease. All therapy received prior to a diagnosis of metastatic disease (eg, neoadjuvant, adjuvant or repeated adjuvant therapy following a second resection) is counted as one regimen.
- Patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate hematopoietic, liver and kidney functions.
Exclusion Criteria (major highlights):
- Patient with chemotherapy within 21 days, radiotherapy within 14 days, biological therapy with 14 days, hormonal therapy within 7 days and investigational therapy within 21 days prior to randomization.
- Patient with any major surgery within 28 days prior to randomization.
- Patient with concurrent use of biologic agents for the treatment of cancer including antibodies or any investigational agent(s).
- Patient with prior treatment for cancer with a camptothecin derivative.
- Patient with chronic or acute GI disorders resulting in diarrhea of any severity grade; patients who are using chronic anti-diarrheal supportive care to control diarrhea in the 28 days prior to randomization.
- Patient received pharmacotherapy for hepatitis B or C, tuberculosis or HIV.
- Patient with known cirrhosis diagnosed with Child-PUGH Class A or higher liver disease.
- Patient with prior malignancy (other than breast cancer) except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 5 years prior to randomization.
- Patient requiring daily use of oxygen supplementation in the 28 days prior to randomization.
- Patients with significant cardiovascular impairment.
Data sourced from ClinicalTrials.gov (NCT01492101). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.