Study to compare NKTR-102 (also called the ''study drug'') with standard treatments for breast cancer (also called ''treatment of physician's choice'').

Phase 1

Conditions: ocally Recurrent Breast Cancer, Metastatic Breast Cancer
MedDRA version: 14.1Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1Level: PTClassification code 10006198Term: Breast cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2011-003832-30-IT

Lead Sponsor: EKTAR THERAPEUTICS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 840

Inclusion Criteria

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 function
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 672
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 168

Exclusion Criteria

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