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: 17.0Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 17.0Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 17.0Level: 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-BE

Lead Sponsor: ektar Therapeutics

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

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. Patients may have either measurable disease by RECIST version 1.1 or non-measurable disease.
•Locally recurrent or metastatic disease that is not resectable or amenable to curative treatment.
•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. Treatment regimens for ipsilateral and/or contralateral recurrent disease (ie, multiple adjuvant therapies) are permitted and all counted as one regimen.
•Patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•Adequate hematopoietic, liver and kidney functions.

Are the trial subjects under 18? no
Number of subjects for this age range:
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 who have had a last dose of IV chemotherapy within 21 days, last dose of oral chemotherapy, radiotherapy, biological therapy, or investigational therapy within 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 the 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.