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A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine

Primary Purpose

Breast Neoplasms

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Capecitabine

Sunitinib malate

About this trial

This is an interventional treatment trial for Breast Neoplasms focused on measuring advanced breast cancer, metastatic breast cancer, treatment resistant, treatment failure

Eligibility Criteria

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

Inclusion Criteria:

breast adenocarcinoma
prior treatment with an anthracycline and a taxane either concurrently or sequentially in the neoadjuvant, adjuvant and or/ advanced disease treatment settings. No more than 1 chemotherapy regimen in the advanced setting

Exclusion Criteria:

Prior treatment with regimens of chemotherapy in the advanced/metastatic disease setting beyond those containing anthracyclines and taxanes or multiple anthracyclines/ taxanes treatments.
Any prior regimen with capecitabine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

1250 mg/m^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles

37.5 mg daily, continuous dosing

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)

Time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occured first.

Secondary Outcome Measures

Time to Tumor Progression (TTP)

Time from randomization to first documentation of objective tumor progression.

Number of Participants With Overall Response (OR)

OR was defined as the number of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.0) for at least 4 weeks, confirmed by repeat tumor assessments. CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to (>=) 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Duration of Response (DR)

Time from the first documentation of OR (CR or PR) that was subsequently confirmed to the first documentation of tumor progression or death due to any cause. CR was defined as disappearance of all target lesions. PR was defined as a >= 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.

Time to Tumor Response (TTR)

Time from randomization to the first documentation of objective tumor response (CR or PR) that was subsequently confirmed. CR was defined as disappearance of all target lesions. PR was defined as a >= 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.

Overall Survival (OS)

Average time from randomization to first documentation of death due to any cause.

European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)

EORTC QLQ-C30 scales: functional (physical/role/cognitive/emotional/social), symptom (fatigue/nausea/vomiting/pain), global health/QOL, cancer symptom (dyspnea/insomnia/appetite loss/constipation/diarrhea). Feelings in past week: response range: not at all to very much, global/QOL range: very poor to excellent. Scales/single-items averaged, score 0 to 100. Higher functional/global=better functioning and symptom=greater degree of symptoms.

EORTC QLQ Breast Cancer Module (BR23)

BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score implied a greater degree of symptoms.

Full Information

NCT ID

NCT00373113

First Posted

September 5, 2006

Last Updated

June 15, 2012

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00373113

Brief Title

A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine

Official Title

Phase III Randomized, Multi Center Study Of Sunitinib Malate (SU 011248) Or Capecitabine In Subjects With Advanced Breast Cancer Who Failed Both A Taxane And An Anthracycline Chemotherapy Regimen Or Failed With A Taxane And For Whom Further Anthracycline Therapy Is Not Indicated

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Terminated

Why Stopped

See termination reason in detailed description.

Study Start Date

November 2006 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To compare efficacy and safety of Sunitinib and Capecitabine in subjects with advanced breast cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated

Detailed Description

Patient enrollment in this trial was discontinued based on statistical assessment for futility. An independent Data Monitoring Committee found that even if the trial had been allowed to continue, treatment with single agent sunitinib would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival compared with single agent capecitabine in the study population. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings on 25Mar2009. Patients receiving sunitinib will be allowed to receive capecitabine or enter an extension trial if they are receiving clinical benefit from continued sunitinib therapy. There were no safety concerns leading to the decision to terminate the study.

6. Conditions and Keywords

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

Breast Neoplasms

Keywords

advanced breast cancer, metastatic breast cancer, treatment resistant, treatment failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

482 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

1250 mg/m^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles

Arm Title

Arm Type

Experimental

Arm Description

37.5 mg daily, continuous dosing

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Other Intervention Name(s)

xeloda

Intervention Description

1250 mg/m^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles

Intervention Type

Drug

Intervention Name(s)

Sunitinib malate

Other Intervention Name(s)

sunitinib

Intervention Description

37.5 mg daily, continuous dosing

Primary Outcome Measure Information:

Title

Progression-Free Survival (PFS)

Description

Time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occured first.

Time Frame

From time of randomization to every 6 weeks thereafter through 22 months or until death

Secondary Outcome Measure Information:

Title

Time to Tumor Progression (TTP)

Description

Time from randomization to first documentation of objective tumor progression.

Time Frame

From time of randomization to every 6 weeks thereafter through 22 months

Title

Number of Participants With Overall Response (OR)

Description

Time Frame

From time of randomization to every 6 weeks thereafter through 22 months

Title

Duration of Response (DR)

Description

Time Frame

From time of randomization to every 6 weeks thereafter through 22 months or death

Title

Time to Tumor Response (TTR)

Description

Time Frame

From time of randomization to every 6 weeks thereafter through 22 months

Title

Overall Survival (OS)

Description

Average time from randomization to first documentation of death due to any cause.

Time Frame

From time of randomization until death

Title

European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)

Description

Time Frame

From Day 1 of Cycle 1, then odd numbered cycles thereafter

Title

EORTC QLQ Breast Cancer Module (BR23)

Description

Time Frame

From Day 1 of Cycle 1, then odd numbered cycles thereafter

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: breast adenocarcinoma prior treatment with an anthracycline and a taxane either concurrently or sequentially in the neoadjuvant, adjuvant and or/ advanced disease treatment settings. No more than 1 chemotherapy regimen in the advanced setting Exclusion Criteria: Prior treatment with regimens of chemotherapy in the advanced/metastatic disease setting beyond those containing anthracyclines and taxanes or multiple anthracyclines/ taxanes treatments. Any prior regimen with capecitabine

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Bahia Blanca

State/Province

Prov. de Buenos Aires

ZIP/Postal Code

B8001HXM

Country

Argentina

Facility Name

Pfizer Investigational Site

City

Viedma

State/Province

Rio Negro

ZIP/Postal Code

8500

Country

Argentina

Facility Name

Pfizer Investigational Site

City

Rosario

State/Province

Santa Fé

ZIP/Postal Code

(2000)

Country

Argentina

Facility Name

Pfizer Investigational Site

City

Buenos Aires

ZIP/Postal Code

C1034ACO

Country

Argentina

Facility Name

Pfizer Investigational Site

City

Buenos Aires

ZIP/Postal Code

C1405BCH

Country

Argentina

Facility Name

Pfizer Investigational Site

City

Cordoba

ZIP/Postal Code

X5000AAI

Country

Argentina

Facility Name

Pfizer Investigational Site

City

Tucuman

ZIP/Postal Code

T4000IAK

Country

Argentina

Facility Name

Pfizer Investigational Site

City

Darlinghurst

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

Pfizer Investigational Site

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

Pfizer Investigational Site

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Pfizer Investigational Site

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

Pfizer Investigational Site

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

Pfizer Investigational Site

City

Perth

State/Province

Western Australia

ZIP/Postal Code

6000

Country

Australia

Facility Name

Pfizer Investigational Site

City

Curitiba

State/Province

ZIP/Postal Code

80530-010

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Rio de Janeiro

State/Province

ZIP/Postal Code

20560-120

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Porto Alegre

State/Province

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Porto Alegre

State/Province

ZIP/Postal Code

91350-200

Country

Brazil

Facility Name

Pfizer Investigational Site

City

São Paulo

State/Province

ZIP/Postal Code

01246-000

Country

Brazil

Facility Name

Pfizer Investigational Site

City

São Paulo

State/Province

ZIP/Postal Code

01509-900

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Sofia

ZIP/Postal Code

1233

Country

Bulgaria

Facility Name

Pfizer Investigational Site

City

Sofia

ZIP/Postal Code

1527

Country

Bulgaria

Facility Name

Pfizer Investigational Site

City

Sofia

ZIP/Postal Code

1756

Country

Bulgaria

Facility Name

Pfizer Investigational Site

City

Stara Zagora

ZIP/Postal Code

6000

Country

Bulgaria

Facility Name

Pfizer Investigational Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 1V7

Country

Canada

Facility Name

Pfizer Investigational Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

Pfizer Investigational Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 3A7

Country

Canada

Facility Name

Pfizer Investigational Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4L6

Country

Canada

Facility Name

Pfizer Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

Pfizer Investigational Site

City

Quebec

ZIP/Postal Code

G1S 4L8

Country

Canada

Facility Name

Pfizer Investigational Site

City

Temuco

State/Province

IX Región

ZIP/Postal Code

4810469

Country

Chile

Facility Name

Pfizer Investigational Site

City

Medellin

State/Province

Antioquia

Country

Colombia

Facility Name

Pfizer Investigational Site

City

Bogotá

State/Province

Cundinamarca

Country

Colombia

Facility Name

Pfizer Investigational Site

City

Bayonne

ZIP/Postal Code

64100

Country

France

Facility Name

Pfizer Investigational Site

City

Besancon

ZIP/Postal Code

25030

Country

France

Facility Name

Pfizer Investigational Site

City

Clermont Ferrand

ZIP/Postal Code

63011

Country

France

Facility Name

Pfizer Investigational Site

City

Lille

ZIP/Postal Code

59020 Cedex

Country

France

Facility Name

Pfizer Investigational Site

City

Neuilly Sur Seine

ZIP/Postal Code

92200

Country

France

Facility Name

Pfizer Investigational Site

City

Nice

ZIP/Postal Code

06100

Country

France

Facility Name

Pfizer Investigational Site

City

Rennes Cedex

ZIP/Postal Code

35042

Country

France

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

12200

Country

Germany

Facility Name

Pfizer Investigational Site

City

Frankfurt

ZIP/Postal Code

60488

Country

Germany

Facility Name

Pfizer Investigational Site

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Pfizer Investigational Site

City

Jena

ZIP/Postal Code

07743

Country

Germany

Facility Name

Pfizer Investigational Site

City

Kiel

ZIP/Postal Code

24103

Country

Germany

Facility Name

Pfizer Investigational Site

City

Leer

ZIP/Postal Code

26789

Country

Germany

Facility Name

Pfizer Investigational Site

City

Luebeck

ZIP/Postal Code

23538

Country

Germany

Facility Name

Pfizer Investigational Site

City

Magdeburg

ZIP/Postal Code

39130

Country

Germany

Facility Name

Pfizer Investigational Site

City

Mainz

ZIP/Postal Code

55101

Country

Germany

Facility Name

Pfizer Investigational Site

City

Meiningen

ZIP/Postal Code

98617

Country

Germany

Facility Name

Pfizer Investigational Site

City

Muenchen

ZIP/Postal Code

81675

Country

Germany

Facility Name

Pfizer Investigational Site

City

Offenburg

ZIP/Postal Code

77652

Country

Germany

Facility Name

Pfizer Investigational Site

City

Tuebingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Pfizer Investigational Site

City

Hong Kong

Country

Hong Kong

Facility Name

Pfizer Investigational Site

City

Kowloon

Country

Hong Kong

Facility Name

Pfizer Investigational Site

City

Tuen Mun

Country

Hong Kong

Facility Name

Pfizer Investigational Site

City

Wan Chai,

Country

Hong Kong

Facility Name

Pfizer Investigational Site

City

Navrangpura / Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380 009

Country

India

Facility Name

Pfizer Investigational Site

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560 078

Country

India

Facility Name

Pfizer Investigational Site

City

Ludhiana

State/Province

Punjab

ZIP/Postal Code

141 008

Country

India

Facility Name

Pfizer Investigational Site

City

Jaipur

State/Province

Rajasthan

ZIP/Postal Code

302013

Country

India

Facility Name

Pfizer Investigational Site

City

Lucknow

State/Province

Uttar Pradesh

ZIP/Postal Code

226003

Country

India

Facility Name

Pfizer Investigational Site

City

Firenze

ZIP/Postal Code

50134

Country

Italy

Facility Name

Pfizer Investigational Site

City

Milano

ZIP/Postal Code

20162

Country

Italy

Facility Name

Pfizer Investigational Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Pfizer Investigational Site

City

Reggio Emilia

ZIP/Postal Code

42100

Country

Italy

Facility Name

Pfizer Investigational Site

City

Nagoya

State/Province

Aichi

Country

Japan

Facility Name

Pfizer Investigational Site

City

Matsuyama-shi

State/Province

Ehime

Country

Japan

Facility Name

Pfizer Investigational Site

City

Kitakyushu-City

State/Province

Fukuoka

Country

Japan

Facility Name

Pfizer Investigational Site

City

Suita

State/Province

Osaka

Country

Japan

Facility Name

Pfizer Investigational Site

City

Kita-adachi-gun

State/Province

Saitama

Country

Japan

Facility Name

Pfizer Investigational Site

City

Bunkyo-ku

State/Province

Tokyo

Country

Japan

Facility Name

Pfizer Investigational Site

City

Chuo-Ku

State/Province

Tokyo

Country

Japan

Facility Name

Pfizer Investigational Site

City

Fukuoka

Country

Japan

Facility Name

Pfizer Investigational Site

City

Osaka

Country

Japan

Facility Name

Pfizer Investigational Site

City

Goyang-si

State/Province

Gyeonggi-do

ZIP/Postal Code

410-769

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Daegu

ZIP/Postal Code

705-717

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Incheon

ZIP/Postal Code

400-711

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Pusan

ZIP/Postal Code

602-739

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Mexico

State/Province

ZIP/Postal Code

11000

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Toluca

State/Province

Estado de Mexico

ZIP/Postal Code

50180

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Acapulco

State/Province

Guerrero

ZIP/Postal Code

39670

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Morelia

State/Province

Michoacan

ZIP/Postal Code

58020

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Ciudad Obregon

State/Province

Sonora

ZIP/Postal Code

85000

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Chihuahua

ZIP/Postal Code

31000

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Puebla

ZIP/Postal Code

72530

Country

Mexico

Facility Name

Pfizer Investigational Site

City

Lima

ZIP/Postal Code

05127

Country

Peru

Facility Name

Pfizer Investigational Site

City

Lima

ZIP/Postal Code

L 27

Country

Peru

Facility Name

Pfizer Investigational Site

City

Quezon City

ZIP/Postal Code

1100

Country

Philippines

Facility Name

Pfizer Investigational Site

City

Quezon City

ZIP/Postal Code

1102

Country

Philippines

Facility Name

Pfizer Investigational Site

City

Quezon City

ZIP/Postal Code

1104

Country

Philippines

Facility Name

Pfizer Investigational Site

City

San Juan City

ZIP/Postal Code

1000

Country

Philippines

Facility Name

Pfizer Investigational Site

City

Singapore

ZIP/Postal Code

119074

Country

Singapore

Facility Name

Pfizer Investigational Site

City

Singapore

ZIP/Postal Code

169610

Country

Singapore

Facility Name

Pfizer Investigational Site

City

Parktown

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Sandton

ZIP/Postal Code

2199

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Mataro

State/Province

Barcelona

ZIP/Postal Code

08304

Country

Spain

Facility Name

Pfizer Investigational Site

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

Facility Name

Pfizer Investigational Site

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

Facility Name

Pfizer Investigational Site

City

Alcorcon

State/Province

Madrid

ZIP/Postal Code

28922

Country

Spain

Facility Name

Pfizer Investigational Site

City

Bilbao

State/Province

Vizcaya

ZIP/Postal Code

48013

Country

Spain

Facility Name

Pfizer Investigational Site

City

Cordoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Pfizer Investigational Site

City

Gerona

ZIP/Postal Code

17007

Country

Spain

Facility Name

Pfizer Investigational Site

City

Jaen

ZIP/Postal Code

23007

Country

Spain

Facility Name

Pfizer Investigational Site

City

La Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

Pfizer Investigational Site

City

Las Palmas de Gran Canaria

ZIP/Postal Code

35016

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28033

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Pfizer Investigational Site

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Pfizer Investigational Site

City

Salamanca

ZIP/Postal Code

37007

Country

Spain

Facility Name

Pfizer Investigational Site

City

Changhua

ZIP/Postal Code

500

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Kaohsiung

ZIP/Postal Code

807

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Taipei

ZIP/Postal Code

106

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Pfizer Investigational Site

City

Istanbul

ZIP/Postal Code

34390

Country

Turkey

Facility Name

Pfizer Investigational Site

City

Cardiff

State/Province

South Wales

ZIP/Postal Code

CF14 2TL

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Nottingham

ZIP/Postal Code

NG5 1PB

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Somerset

ZIP/Postal Code

BA21 4AT

Country

United Kingdom

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181107&StudyName=A%20Clinical%20Trial%20Comparing%20Efficacy%20And%20Safety%20Of%20Sunitinib%20And%20Capecitabine

Description

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Learn more about this trial

A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine

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A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine

Breast Neoplasms

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

Learn more about this trial