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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02915744




Registration number
NCT02915744
Ethics application status
Date submitted
22/09/2016
Date registered
27/09/2016
Date last updated
14/04/2023

Titles & IDs
Public title
A Study of Etirinotecan Pegol (NKTR-102) Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and Capecitabine
Scientific title
A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and Capecitabine
Secondary ID [1] 0 0
15-102-14
Universal Trial Number (UTN)
Trial acronym
ATTAIN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastasis 0 0
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: NKTR-102 - In Group A, NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.

Active comparator: Treatment of Physician's Choice (TPC) - In Group B, TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) of Patients
Timepoint [1] 0 0
Within 3 years from study start
Secondary outcome [1] 0 0
Progression-Free Survival (Outside the Central Nervous System)
Timepoint [1] 0 0
Through study completion, an expected average of 1 year
Secondary outcome [2] 0 0
Progression-Free Survival in Brain Metastasis (PFS-BM)
Timepoint [2] 0 0
Through study completion, an expected average of 1 year
Secondary outcome [3] 0 0
Progression-Free Survival (Overall)
Timepoint [3] 0 0
Through study completion, an expected average of 1 year
Secondary outcome [4] 0 0
Objective Response Rates (ORR) of the NKTR-102 Treatment and the Treatment of Physician's Choice (TPC)
Timepoint [4] 0 0
Through study completion, an expected average of 1 year
Secondary outcome [5] 0 0
Clinical Benefit Rate (CBR)
Timepoint [5] 0 0
For at least 4 months, with an expected average of 1 year
Secondary outcome [6] 0 0
Duration of Response (DoR)
Timepoint [6] 0 0
Through study completion, an expected average of 1 year
Secondary outcome [7] 0 0
Compare Health-Related Quality of Life (HRQoL) Using the European Organisation for Treatment of Cancer (EORTC) Quality of Life Core 30 (QLQ-C30) Module With the Brain Neoplasms 20-question (BN-20) Subscale.
Timepoint [7] 0 0
Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 for NKTR-102 or 28 days for TPC] and end of Cycle 44.
Secondary outcome [8] 0 0
Compare Health-Related Quality of Life (HRQoL) Using the the EuroQoL 5D (EQ-5D-5L™)
Timepoint [8] 0 0
Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 for NKTR-102 or 28 days for TPC] and end of Cycle 44
Secondary outcome [9] 0 0
Compare Health-Related Quality of Life (HRQoL) Using the Brief Fatigue Inventory (BFI)
Timepoint [9] 0 0
Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 for NKTR-102 or 28 days for TPC] and end of Cycle 44
Secondary outcome [10] 0 0
Magnitude of Clinical Benefit Assessed by ESMO-MCBS Derived From Overall Survival
Timepoint [10] 0 0
Through study completion, within 3 years from study start
Secondary outcome [11] 0 0
Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.3
Timepoint [11] 0 0
Through study completion, an expected average of 1 year

Eligibility
Key inclusion criteria
* Female or male, age = 18 years.
* Histologically-confirmed carcinoma of the breast (either the primary or metastatic lesions) for whom single-agent cytotoxic chemotherapy is indicated. Patients may have either measurable or non-measurable disease according to RECIST version 1.1.
* Patients must have a history of brain metastases that are non-progressing.
* For triple-negative breast cancer, a minimum of 1 prior cytotoxic chemotherapy regimen must have been administered for the indication of metastatic disease.Depending on receptor status, 1 or 2 prior cytotoxic regimens are required prior to enrollment in this trial; hormonal and/or human epidermal growth factor receptor 2 (HER2) -targeted agents may be required.
* Have had prior therapy (administered in the neoadjuvant, adjuvant, and/or metastatic setting) with an anthracycline, a taxane, and capecitabine (prior anthracycline can be omitted if not medically appropriate or contraindicated for the patient).
* Last dose of anticancer therapy must have been administered within 6 months of the date of randomization into this study.
* All anticancer- and radiation therapy-related toxicities must be completely resolved or downgraded to Grade 1 or less (neuropathy may be Grade 2 or less).
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Demonstrate adequate organ function obtained within 14 days prior to randomization and analyzed by the central laboratory.
* Women of childbearing potential (WCBP) must agree to use highly effective methods of birth control throughout the duration of the study until 6 months following the last dose of study drug.
* Males with female partners of child-bearing potential must agree to use a barrier contraception (e.g., condom with spermicidal foam/gel/film/cream/suppository) throughout the duration of the study until 6 months following the last dose of study drug; in addition to their female partner using either an intrauterine device or hormonal contraception and continuing until 6 months following the last dose of study drug. Male patients should not donate sperm until 6 months following the last dose of study drug.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Last dose of anticancer therapy (including HER2-targeted therapy) within 14 days prior to randomization.
* High-dose chemotherapy followed by stem cell transplantation (autologous or allogeneic).
* Major surgery within 28 days prior to randomization.
* Concomitant use of any anticancer therapy or use of any investigational agent(s).
* Received prior treatment for cancer with a camptothecin-derived agent.
* Lesions on imaging, by cerebrospinal fluid or with neurological findings that are consistent with leptomeningeal disease or meningeal carcinomatosis.
* Chronic or acute GI disorders resulting in diarrhea of any severity grade.
* Patients who are pregnant or lactating, plan to get pregnant, or have a positive serum pregnancy test prior to randomization.
* Enzyme-inducing anti-epileptic drugs (EIAEDs) within 14 days of randomization.
* Hepatitis B or C, tuberculosis, or HIV.
* Cirrhosis.
* Prior malignancy (other than breast cancer) unless diagnosed and definitively treated more than 5 years prior to randomization.
* Daily use of oxygen supplementation.
* Significant known cardiovascular impairment.
* Prior treatment with NKTR-102.
* Psychiatric illness, social situation, or geographical situation that preclude informed consent or limit compliance.
* Known intolerance or hypersensitivity to any of the products used in this study or their excipients.
* For patients selecting vinorelbine or gemcitabine as the TPC agent, patients may not receive yellow fever vaccine in the 28 days prior to randomization.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2020
Sample size
Target
Accrual to date
Final
178
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Investigatory Site - Albury - Albury
Recruitment hospital [2] 0 0
Investigator Site - Darlinghurst - Darlinghurst
Recruitment hospital [3] 0 0
Investigator Site - Wollongong - Wollongong
Recruitment hospital [4] 0 0
Investigator Site - Subiaco - Subiaco
Recruitment hospital [5] 0 0
Investigator Site - Box Hill - Box Hill
Recruitment hospital [6] 0 0
Investigator Site - Nedlands - Nedlands
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
6008 - Subiaco
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Utah
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Belgium
State/province [16] 0 0
Brussels
Country [17] 0 0
Belgium
State/province [17] 0 0
Charleroi
Country [18] 0 0
Belgium
State/province [18] 0 0
Edegem
Country [19] 0 0
Belgium
State/province [19] 0 0
Liège
Country [20] 0 0
Belgium
State/province [20] 0 0
Woluwe-Saint-Lambert
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
France
State/province [22] 0 0
Le Mans
Country [23] 0 0
France
State/province [23] 0 0
Nîmes
Country [24] 0 0
France
State/province [24] 0 0
Paris
Country [25] 0 0
France
State/province [25] 0 0
Rennes
Country [26] 0 0
France
State/province [26] 0 0
Rouen
Country [27] 0 0
France
State/province [27] 0 0
Strasbourg
Country [28] 0 0
Israel
State/province [28] 0 0
Beersheba
Country [29] 0 0
Israel
State/province [29] 0 0
Haifa
Country [30] 0 0
Israel
State/province [30] 0 0
Tel Aviv
Country [31] 0 0
Italy
State/province [31] 0 0
Milano
Country [32] 0 0
Italy
State/province [32] 0 0
Milan
Country [33] 0 0
Italy
State/province [33] 0 0
Napoli
Country [34] 0 0
Italy
State/province [34] 0 0
Roma
Country [35] 0 0
Portugal
State/province [35] 0 0
Lisboa
Country [36] 0 0
Portugal
State/province [36] 0 0
Porto
Country [37] 0 0
Spain
State/province [37] 0 0
Barcelona
Country [38] 0 0
Spain
State/province [38] 0 0
Madrid
Country [39] 0 0
Spain
State/province [39] 0 0
Santa Cruz de Tenerife
Country [40] 0 0
Spain
State/province [40] 0 0
Sevilla
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Bradford
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Manchester
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Nektar Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02915744