The BEACON Study (BrEAst Cancer Outcomes with NKTR-102): A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 versus Treatment of Physician*s Choice (TPC) in Patients with Locally Recurrent or Metastatic Breast Cancer Previously Treated with an Anthracycline, a Taxane, and Capecitabine

Phase 3

Conditions: Metastatic Breast Cancer
10006291

Registration Number: NL-OMON41606

Lead Sponsor: ektar Therapeutics

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

*An eligible patient is an adult female with histologically or cytologically
confirmed carcinoma of the breast. Patients may have either measurable
by RECIST v1.1 or non-measurable disease, locally recurrent or metastatic disease that is not resectable or amenable to curative treatment.
Prior therapy (administered in the neoadjuvant, adjuvant and/or metastatic
setting) must include an anthracycline (unless not medically appropriate or
contraindicated for the patient), a taxane, and Xeloda® (capecitabine). Patients
must have received a minimum of two and a maximum of five prior cytotoxic
chemotherapy regimens for the treatment of breast cancer, with the last dose
administered within 6 months of the date of consent for this trial. Patients must
have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
1 with adequate organ function. Patients with brain metastases may be eligible,
provided local therapy was completed and use of corticosteroids for this
indication discontinued for at least 3 weeks prior to randomization with stable
brain metastases (by symptoms and imaging).
The complete list of inclusion and exclusion criteria is provided in Section 5.0 .

Exclusion Criteria

*Patient who have had a last dose of IV chemotherapy within 21 days, last dose of oral chemotherapy, radiotherapy within 14 days, biological therapy with 14 days or hormonal therapy within 7 days prior to randomization. Patients who have undergone high-dose chemotherapy followed by stem cell transplantation (autologous or allogeneic). Refer to Study Reference Manual for categories of anticancer therapies;*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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoint is Overall Survival</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>secondary endpoint is<br /><br>objective response rate,<br /><br>progression free survival,<br /><br>clinical benefit rate,<br /><br>Duration of Response,<br /><br>Incidence and severity of treatment-emergent adverse events (TEAEs), laboratory<br /><br>abnormalities, targeted symptoms (including diarrhea and neuropathy); incidence<br /><br>of dose reductions; dose intensity<br /><br>QLQ-C30 individual scale, overall score and BR23 score value and change over<br /><br>the time of study participation<br /><br>Derived PK parameters, including Cmax, AUC, time to Cmax (Tmax), V, elimination<br /><br>t* and CL, with an exploratory analysis regarding possible correlation to<br /><br>various baseline characteristics (eg, age and UGT1A1 status)<br /><br>Selected measures of health care utilization<br /><br>Quantification of CTCs and assessment of various biomarkers (eg, topoisomerase<br /><br>1 and 2 expression, DNA damage and apoptosis at baseline); change from baseline</p><br>