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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 (ATTAIN)

Primary Purpose

Metastasis, Breast Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

NKTR-102

Eribulin

Ixabepilone

Vinorelbine

Gemcitabine

Paclitaxel

Docetaxel

Nab-paclitaxel

About this trial

This is an interventional treatment trial for Metastasis focused on measuring Breast Cancer Brain Metastases (BCBM), Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NKTR-102

Treatment of Physician's Choice (TPC)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Overall Survival (OS) of Patients

To compare Overall Survival (OS) of patients who receive 145 mg/m2 NKTR-102 given once every 21 days (q21d) with OS of patients who receive Treatment of Physician's Choice (TPC). Overall survival is defined as the time from the date of randomization to the date of death from any cause. Patients will be followed until their date of death or until final database closure. Patients who are lost-to-follow-up or are alive at the time of analysis will be censored at the time they were last known to be alive or at the date of event cut-off for OS analysis.

Secondary Outcome Measures

Progression-Free Survival (Outside the Central Nervous System)

Progression-Free Survival (PFS) is defined as the time from the date of randomization to the earliest evidence of documented Progressive Disease (PD) or of death from any cause. The date of global deterioration or symptomatic deterioration will not be used as the date of PD. The assessment of PFS outside the CNS will utilize RECIST criteria v1.1.

Progression-Free Survival in Brain Metastasis (PFS-BM)

Progression-Free Survival in Brain Metastasis (PFS-BM) is defined as the time from the date of randomization to the earliest evidence of documented Progressive Disease (PD) per Response Assessment in Neuro-Oncology-Brain Metastases (RANO-BM) in brain metastases or death from any cause. The PD will also be determined by the investigator's assessments. Progressive Disease (PD) is defined as at least a 20% increase in the sum of longest diameters of CNS target lesions, taking as reference the smallest sum on study. This included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, at least 1 lesion had to increase by an absolute value of 5 mm or more to be considered progression.

Progression-Free Survival (Overall)

Progression-free survival (CNS and peripheral) is defined as the time from the date of randomization to the earliest evidence of documented PD in either the CNS or peripheral (using RANO-BM) or death from any cause. The PD will be determined by both the investigator's and the central imaging facility assessments. The same statistical methods that were used for PFS and PFS-BM will be used for PFS (Overall). Progressive Disease (PD) is defined as at least a 20% increase in the sum of longest diameters of CNS target lesions, taking as reference the smallest sum on study. This included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, at least 1 lesion had to increase by an absolute value of 5 mm or more to be considered progression.

Objective Response Rates (ORR) of the NKTR-102 Treatment and the Treatment of Physician's Choice (TPC)

RECIST criteria for lesions outside the Central Nervous System (CNS); RANO-BM criteria for CNS lesions) based upon the best response as assessed by the central imaging facility. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR is calculated as the sum of CR and PR. Progressive Disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Clinical Benefit Rate (CBR)

Clinical Benefit Rate will be defined as the proportion of patients having a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) for at least 4 months (≥ 120 days). CR is defined as disappearance of all target lesions for at least 4 weeks with no new lesions, not use of corticosteroids, and patient was stable or improved clinically. PR is defined as at least a 30% decrease in the sum of longest diameters sustained for at least 4 weeks, no new lesions; stable to decreased corticosteroid dose; stable or improved clinically. Progressive Disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Duration of Response (DoR)

Duration of response (DoR) outside the CNS will be defined as the time from first documented CR or PR until the earliest evidence of disease progression per RECIST v1.1 or death from any cause. CR is defined as disappearance of all target lesions for at least 4 weeks with no new lesions, not use of corticosteroids, and patient was stable or improved clinically. PR is defined as at least a 30% decrease in the sum of longest diameters sustained for at least 4 weeks, no new lesions; stable to decreased corticosteroid dose; stable or improved clinically. Progressive Disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

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.

The EORTC QLQ-BN20 Scale has a series of 20 questions each of which involve reporting a scale from 1-4. It is an increasing scale where a score of one indicates "not at all" while a score of four indicates "very much". The minimum score is 20 and the maximum score is 80. The higher the score the worse the outcome.

Compare Health-Related Quality of Life (HRQoL) Using the the EuroQoL 5D (EQ-5D-5L™)

The EQ-5D-5L scale is used to measure health by having a patient answer a series of questions. There are a series of 5 questions each of which is scaled from a score of 4-20 in increasing increments of 4. The scale is numbered from 0 to 100 where 100 means the beast health you can imagine and 0 means the worst health.

Compare Health-Related Quality of Life (HRQoL) Using the Brief Fatigue Inventory (BFI)

The Brief Fatigue Inventory scale utilizes a series of 4 questions. The first three are scored with a scale from 1-10. The fourth question has 6 six sub components each of which are scored with a scale of 1-10. For every scale, a score of 0 indicates no fatigue/interference where a score of 10 indicates as bad as you can imagine. A patient's score can range from 0 to 100 where 0 indicates the best outcome and 100 indicates the worst.

Magnitude of Clinical Benefit Assessed by ESMO-MCBS Derived From Overall Survival

The magnitude of clinical benefit of NKTR-102 is assessed by the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) (v1.0). The scale is graded 5, 4, 3, 2, 1, where grades 5 and 4 represent a high level of proven clinical benefit, and grade 1 represents no clinical benefit. To determine the magnitude of clinical benefit when the median OS with the standard of treatment is ≤ 1 year, the score is derived from the Hazard Ratio (HR) of Overall Survival, overall survival gain, and QoL improvement between two treatment arms. Values reported in the data table are Overall Survival values.

Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.3

The number of participants with adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.3

Full Information

NCT ID

NCT02915744

First Posted

September 22, 2016

Last Updated

April 10, 2023

Sponsor

Nektar Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT02915744

Brief 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

Acronym

ATTAIN

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

November 2016 (undefined)

Primary Completion Date

July 2020 (Actual)

Study Completion Date

July 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nektar Therapeutics

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Detailed Description

This is an open-label, randomized, active comparator, multicenter, international Phase 3 study of NKTR-102 versus TPC in patients with metastatic breast cancer who have stable brain metastases and have been previously treated with an anthracycline, a taxane, and capecitabine in either the adjuvant or metastatic setting (prior anthracycline may be omitted if medically appropriate or contraindicated for the patient). 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. 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. This study will randomize approximately 220 patients using a 1:1 randomization ratio and stratification based on geographic region, tumor receptor status, and Eastern Cooperative Oncology Group (ECOG) status. At Screening, the Investigator must determine which TPC will be offered to the patient. Data will be collected on subsequent anticancer therapies in both treatment groups from the time patients come off the study treatment until the time of primary data analysis for Overall Survival (OS). An independent data monitoring committee (DMC) will assess interim safety and efficacy data and determine final number of death events needed to provide 80% conditional power based on the zone adaptive design.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastasis, Breast Cancer

Keywords

Breast Cancer Brain Metastases (BCBM), Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

178 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NKTR-102

Arm Type

Experimental

Arm Description

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.

Arm Title

Treatment of Physician's Choice (TPC)

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

NKTR-102

Intervention Type

Drug

Intervention Name(s)

Eribulin

Intervention Type

Drug

Intervention Name(s)

Ixabepilone

Intervention Type

Drug

Intervention Name(s)

Vinorelbine

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Type

Drug

Intervention Name(s)

Nab-paclitaxel

Primary Outcome Measure Information:

Title

Overall Survival (OS) of Patients

Description

Time Frame

Within 3 years from study start

Secondary Outcome Measure Information:

Title

Progression-Free Survival (Outside the Central Nervous System)

Description

Time Frame

Through study completion, an expected average of 1 year

Title

Progression-Free Survival in Brain Metastasis (PFS-BM)

Description

Time Frame

Through study completion, an expected average of 1 year

Title

Progression-Free Survival (Overall)

Description

Time Frame

Through study completion, an expected average of 1 year

Title

Objective Response Rates (ORR) of the NKTR-102 Treatment and the Treatment of Physician's Choice (TPC)

Description

Time Frame

Through study completion, an expected average of 1 year

Title

Clinical Benefit Rate (CBR)

Description

Time Frame

For at least 4 months, with an expected average of 1 year

Title

Duration of Response (DoR)

Description

Time Frame

Through study completion, an expected average of 1 year

Title

Description

Time Frame

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.

Title

Compare Health-Related Quality of Life (HRQoL) Using the the EuroQoL 5D (EQ-5D-5L™)

Description

Time Frame

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

Title

Compare Health-Related Quality of Life (HRQoL) Using the Brief Fatigue Inventory (BFI)

Description

Time Frame

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

Title

Magnitude of Clinical Benefit Assessed by ESMO-MCBS Derived From Overall Survival

Description

Time Frame

Through study completion, within 3 years from study start

Title

Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.3

Description

The number of participants with adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.3

Time Frame

Through study completion, an expected average of 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. 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.

Facility Information:

Facility Name

Investigator Site - Tucson

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

Facility Name

Investigator Site - Orange

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Investigator Site - San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

Investigator Site - Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Investigator Site - Plantation

City

Plantation

State/Province

Florida

ZIP/Postal Code

33324

Country

United States

Facility Name

Investigator Site - West Palm Beach

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

Investigator Site - Athens

City

Athens

State/Province

Georgia

ZIP/Postal Code

30607

Country

United States

Facility Name

Investigator Site - Baltimore

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

Investigator Site - Boston

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Investigator Site - Minneapolis

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

Investigator Site - Saint Louis

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Investigator Site - New York

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Investigator Site - Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

Investigator Site - Columbus

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Investigator Site - Germantown

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

Investigator Site - Fort Worth

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Investigator Site - Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Investigator Site - Salt Lake City

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84106

Country

United States

Facility Name

Investigator Site - Seattle

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

Investigatory Site - Albury

City

Albury

State/Province

New South Wales

ZIP/Postal Code

2640

Country

Australia

Facility Name

Investigator Site - Darlinghurst

City

Darlinghurst

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

Investigator Site - Wollongong

City

Wollongong

State/Province

New South Wales

ZIP/Postal Code

2500

Country

Australia

Facility Name

Investigator Site - Subiaco

City

Subiaco

State/Province

Western Australia

ZIP/Postal Code

6008

Country

Australia

Facility Name

Investigator Site - Box Hill

City

Box Hill

ZIP/Postal Code

3128

Country

Australia

Facility Name

Investigator Site - Nedlands

City

Nedlands

ZIP/Postal Code

6009

Country

Australia

Facility Name

Investigator Site - Brussels

City

Brussels

ZIP/Postal Code

1000

Country

Belgium

Facility Name

Investigator Site - Brussels

City

Brussels

ZIP/Postal Code

1180

Country

Belgium

Facility Name

Investigator Site - Brussels

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Investigator Site - Charleroi

City

Charleroi

ZIP/Postal Code

6000

Country

Belgium

Facility Name

Investigator Site - Edegem

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Investigator Site - Liege

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Investigator Site - Woluwe- Saint-Lambert

City

Woluwe-Saint-Lambert

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Investigator Site - Montreal

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H4A 3J1

Country

Canada

Facility Name

Investigator Site - Le Mans

City

Le Mans

ZIP/Postal Code

72000

Country

France

Facility Name

Investigator Site - Nimes

City

Nîmes

ZIP/Postal Code

30029

Country

France

Facility Name

Investigator Site - Paris

City

Paris

ZIP/Postal Code

75248

Country

France

Facility Name

Investigator Site - Rennes

City

Rennes

ZIP/Postal Code

35042

Country

France

Facility Name

Investigator Site - Rouen

City

Rouen

ZIP/Postal Code

76038

Country

France

Facility Name

Investigator Site - Strasbourg

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Facility Name

Investigator Site - Beersheba

City

Beersheba

ZIP/Postal Code

84101

Country

Israel

Facility Name

Investigator Site - Haifa

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Investigator Site - Tel Aviv

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Investigator Site - Milano

City

Milano

ZIP/Postal Code

20141

Country

Italy

Facility Name

Investigator Site - Milan

City

Milan

ZIP/Postal Code

20132

Country

Italy

Facility Name

Investigator Site - Napoli

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Investigator Site - Roma

City

Roma

ZIP/Postal Code

144

Country

Italy

Facility Name

Investigator Site - Lisboa

City

Lisboa

ZIP/Postal Code

1649-035

Country

Portugal

Facility Name

Investigator Site - Porto

City

Porto

ZIP/Postal Code

4200-072

Country

Portugal

Facility Name

Investigator Site - Barcelona

City

Barcelona

ZIP/Postal Code

8023

Country

Spain

Facility Name

Investigator Site - Barcelona

City

Barcelona

ZIP/Postal Code

8035

Country

Spain

Facility Name

Investigator Site - Madrid

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Investigator Site - Santa Cruz de Tenerife

City

Santa Cruz de Tenerife

ZIP/Postal Code

38320

Country

Spain

Facility Name

Investigator Site - Sevilla

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Investigator Site - Bradford

City

Bradford

ZIP/Postal Code

BD7 1DP

Country

United Kingdom

Facility Name

Investigator Site - Manchester

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

Investigator Site - Nottingham

City

Nottingham

ZIP/Postal Code

NG5 1PB

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

35552364

Citation

Tripathy D, Tolaney SM, Seidman AD, Anders CK, Ibrahim N, Rugo HS, Twelves C, Dieras V, Muller V, Du Y, Currie SL, Hoch U, Tagliaferri M, Hannah AL, Cortes J; ATTAIN Investigators. Treatment With Etirinotecan Pegol for Patients With Metastatic Breast Cancer and Brain Metastases: Final Results From the Phase 3 ATTAIN Randomized Clinical Trial. JAMA Oncol. 2022 Jul 1;8(7):1047-1052. doi: 10.1001/jamaoncol.2022.0514.

Results Reference

derived

PubMed Identifier

31074641

Citation

Tripathy D, Tolaney SM, Seidman AD, Anders CK, Ibrahim N, Rugo HS, Twelves C, Dieras V, Muller V, Tagliaferri M, Hannah AL, Cortes J. ATTAIN: Phase III study of etirinotecan pegol versus treatment of physician's choice in patients with metastatic breast cancer and brain metastases. Future Oncol. 2019 Jul;15(19):2211-2225. doi: 10.2217/fon-2019-0180. Epub 2019 May 10.

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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 (ATTAIN)

Metastasis, Breast Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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