AzTrials
AzTrials

Breast CancerPhase 3CheckMate 7FLNCT04109066

Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer

A Phase 3 study testing nivolumab, paclitaxel (PTX) and anthracycline in people with Breast Cancer, run by Bristol-Myers Squibb at 240 sites in 32 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
nivolumab, paclitaxel (PTX) and anthracycline
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
521 participants
Where
240 sitesin 32 countries
Study dates
18 Nov 2019to 27 Dec 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Localized invasive breast ductal carcinoma, confirmed by the local pathologist, that includes the following combined primary tumor and clinical node (cN) categories: T1c (tumor size = 2 cm)-T2 (tumor size > 2 cm), cN1-N2 OR T3-T4, cN0-cN2. Note: Axillary lymph node status must be assessed by fine needle biopsy or core biopsy.
  • Estrogen receptor-positive (ER+) breast cancer (BC) and with or without progesterone receptor (PgR) expression (determined on the most recently analyzed tissue sample, tested locally, and confirmed by the central laboratory), as defined in the relevant American Society of Clinical Oncology (ASCO)- College of American Pathologists (CAP) Guidelines.
  • Human epidermal growth factor receptor 2 (HER2-) BC tested in the local laboratory, defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+, or 2+.
  • Tumor Grade 3 of ductal histology, Or Tumor Grade 2 of ductal histology having an ER expression level percentage between 1-10%
  • Must agree to provide primary breast tumor tissue at baseline and at surgery
  • Must be deemed eligible for surgery
  • Males and females must agree to follow specific methods of contraception, if applicable, while participating in the trial
  • Must have an Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or 1

Who cannot join

  • Breastfeeding, pregnant, or expecting to conceive or father children within the projected duration of the study, starting with the screening through 12 months for participants who receive cyclophosphamide, or 6 months for participants who do not receive cyclophosphamide, after the last dose of study treatment
  • Prior treatment with chemotherapy, endocrine therapy (ET), targeted therapy, and/or radiation therapy for the currently diagnosed breast cancer prior to enrollment
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  • Significant cardiovascular disease such as left ventricular ejection fraction (LVEF) < 50% at baseline as assessed by echocardiography (ECHO) or multigated acquisition (MUGA) scan performed at screening, or Class III or IV myocardial disease as described by the New York Heart Association
  • History of ipsilateral invasive BC, regardless of treatment, ipsilateral ductal carcinoma in situ treated with radiation, or contralateral invasive BC, at any time
  • Definitive clinical or radiologic evidence of metastatic disease
Show all 9Show fewer
  • Multicentric BC (the presence of > 1 tumor in different quadrants of the breast)
  • Bilateral invasive BC
  • Other protocol-defined inclusion/exclusion criteria apply

Trial locations and contacts

240 sites in 32 countries.

240 sites in 32 countries

United States30 sites

  • Local Institution - 0181

    Albuquerque, New Mexico, 87131

  • Local Institution - 0054

    Athens, Georgia, 30607

  • Local Institution - 0107

    Atlanta, Georgia, 30342

  • Local Institution - 0146

    Bethesda, Maryland, 20817

  • Local Institution - 0283

    Charlotte, North Carolina, 28204

  • Local Institution - 0221

    Chicago, Illinois, 60611

  • Local Institution - 0053

    Cleveland, Ohio, 44109

  • Local Institution - 0056

    Columbus, Georgia, 31904

  • Duke Cancer Institute

    Durham, North Carolina, 27710

  • Local Institution - 0224

    Fairfax, Virginia, 22031

  • Local Institution - 0109

    Florham Park, New Jersey, 07932

  • Local Institution - 0227

    Fort Wayne, Indiana, 46804

  • Local Institution - 0121

    Fort Worth, Texas, 76104

  • Local Institution - 0122

    Fredericksburg, Virginia, 22408

  • Local Institution - 0052

    Greenbrae, California, 94904

  • Local Institution - 0050

    Hackensack, New Jersey, 07601

  • Local Institution - 0150

    Jacksonville, Florida, 32256

  • HCA Midwest Division

    Kansas City, Missouri, 64132

  • Local Institution - 0097

    Miami, Florida, 33136

  • Local Institution - 0136

    Mobile, Alabama, 36604

  • Local Institution - 0218

    Nashville, Tennessee, 37203

  • Local Institution - 0180

    New Brunswick, New Jersey, 08903

  • Local Institution - 0149

    Pensacola, Florida, 32504

  • Virginia Cancer Institute

    Richmond, Virginia, 23230

  • Local Institution - 0274

    Seattle, Washington, 98109

  • Local Institution - 0182

    Stamford, Connecticut, 06904

  • Local Institution - 0120

    Tallahassee, Florida, 32308

  • Local Institution - 0041

    The Bronx, New York, 10461

  • Local Institution - 0222

    Topsham, Maine, 04086

  • Local Institution - 0051

    Whittier, California, 90603

Other trials in United States

China28 sites

  • Local Institution

    Beijing, Beijing Municipality, 100021

  • Local Institution - 0215

    Beijing, 100044

  • Local Institution - 0235

    Bengbu, Anhui, 233004

  • Local Institution - 0255

    Changchun, Jilin, 130012

  • Local Institution - 0247

    Changchun, Jilin, 130021

  • Local Institution - 0244

    Chengdu, Sichuan, 610041

  • Local Institution - 0319

    Chongqing, Chongqing Municipality, 400016

  • Local Institution - 0232

    Chongqing, Chongqing Municipality, 400030

  • Local Institution - 0267

    Guangzhou, Guangdong, 510060

  • Local Institution - 0241

    Guangzhou, Guangdong, 510080

  • Local Institution

    Guangzhou, Guangdong, 510515

  • Local Institution - 0238

    Hangzhou, Zhejiang, 310000

  • Local Institution - 0231

    Hangzhou, Zhejiang, 310003

  • Local Institution - 0237

    Hangzhou, Zhejiang, 310009

  • Local Institution - 0248

    Harbin, Heilongjiang, 150001

  • Local Institution - 0239

    Hefei, Anhui, 230031

  • Local Institution - 0245

    Jinan, Shandong, 250117

  • Local Institution - 0256

    Qingdao, Shandong, 266000

  • Local Institution - 0127

    Shanghai, Shanghai Municipality, 200032

  • Local Institution - 0252

    Shenyang, Liaoning, 110042

  • Local Institution - 0240

    Shjiazhuang, Hebei, 50051

  • Local Institution - 0254

    Tianjin, Tianjin Municipality, 300060

  • Local Institution - 0311

    Ürümqi, Xinjiang, 830000

  • Local Institution - 0250

    Wuhan, Hebei, 430022

  • Local Institution - 0263

    Xi'an, Shan3xi, 710061

  • Local Institution - 0214

    Yantai, Shandong, 264000

  • Local Institution

    Zhengzhou, Henan

  • Local Institution - 0312

    Zunyi, Guizhou, 563000

Other trials in China

Brazil15 sites

  • Local Institution - 0134

    Barretos, São Paulo, 14784-400

  • Local Institution - 0133

    Belo Horizonte, Minas Gerais, 30130-100

  • Local Institution - 0225

    Brasília, Federal District, 70200-730

  • Local Institution - 0130

    Fortaleza, Ceará, 60135-237

  • Local Institution - 0287

    Goiânia, Goiás, 74605070

  • Local Institution - 0132

    Ijuí, Rio Grande do Sul, 98700-000

  • Local Institution - 0288

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Local Institution - 0131

    Porto Alegre, Rio Grande do Sul, 90050-170

  • Local Institution - 0135

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Local Institution - 0129

    Rio de Janeiro, 22793-080

  • Local Institution - 0273

    Santa Cruz do Sul, Rio Grande do Sul, 96830-180

  • Local Institution - 0128

    Santo André, São Paulo, 09060-870

  • Local Institution - 0272

    São Paulo, São Paulo, 01229-010

  • Local Institution - 0144

    São Paulo, 01317-000

  • Local Institution - 0104

    São Paulo, 04378-500

Other trials in Brazil

Germany15 sites

  • Local Institution - 0083

    Berlin, 13125

  • Local Institution - 0080

    Cologne, 50937

  • Local Institution - 0112

    Dresden, 01307

  • Local Institution - 0081

    Essen, 45147

  • Local Institution - 0158

    Frankfurt, 60590

  • Local Institution - 0223

    Hamburg, 20259

  • Local Institution - 0087

    Heidelberg, 69126

  • Local Institution - 0089

    Homburg, 66421

  • Local Institution - 0196

    Leipzig, 04103

  • Local Institution - 0111

    Mönchengladbach, 41061

  • Local Institution - 0084

    München, Bavaria, 80337

  • Local Institution - 0156

    Rostock, 18059

  • Local Institution - 0079

    Saarbrücken, Saarland, 66113

  • Local Institution - 0157

    Velbert, 42551

  • Local Institution - 0105

    Würzburg, 97080

Other trials in Germany

Argentina12 sites

  • Local Institution - 0020

    Buenos Aires, Buenos Aires F.D., C1417DTB

  • Local Institution - 0013

    Buenos Aires, Distrito Federal, 0

  • Local Institution - 0011

    Caba, Distrito Federal, 1430

  • Local Institution - 0008

    Capital Federal, Distrito Federal, C1280AEB

  • Local Institution - 0012

    Ciudad Autonoma Beunos Aires, Buenos Aires, 1431

  • Local Institution - 0294

    Córdoba, Córdoba Province, X5000FHP

  • Local Institution - 0021

    Córdoba, X5000BAL

  • Local Institution - 0015

    La Plata, Buenos Aires, 1900

  • Local Institution

    La Rioja

  • Local Institution - 0303

    Río Cuarto, Córdoba Province, 5800

  • Local Institution - 0014

    Rosario Santa Fe, Santa Fe Province, S2002KDS

  • Local Institution

    Viedma

Other trials in Argentina

France12 sites

  • Local Institution - 0004

    Besançon, 25030

  • Local Institution - 0024

    Brest, 29200

  • Local Institution - 0162

    Clermont-Ferrand, 63011

  • Local Institution - 0216

    Le Mans, Sarthe, 72000

  • Local Institution - 0153

    Lyon, 69000

  • Local Institution - 0152

    Montpellier, 34298

  • Local Institution - 0161

    Paris, 75908

  • Local Institution - 0195

    Plérin, 22190

  • Local Institution - 0002

    Saint-Herblain, 44805

  • Local Institution - 0258

    Strasbourg, 67085

  • Local Institution - 0228

    Toulon, 83056

  • Local Institution - 0003

    Villejuif, 94800

Other trials in France

Mexico10 sites

  • Local Institution - 0280

    Campeche, 24050

  • Local Institution - 0091

    Chihuahua City, 31000

  • Local Institution - 0145

    Colima, 28018

  • Local Institution - 0212

    Mérida, Yucatán, 97125

  • Local Institution - 0168

    Mexico City, Mexico City, 03100

  • Local Institution - 0154

    Mexico City, Mexico City, 14080

  • Local Institution - 0137

    Monterrey, Nuevo León, 64320

  • Local Institution - 0141

    Oaxaca City, 68020

  • Local Institution - 0262

    Tijuana, Estado de Baja California, 22010

  • Local Institution - 0330

    Zapopan, Jalisco, 45070

Other trials in Mexico

Spain10 sites

  • Local Institution - 0171

    Barcelona, 08035

  • Local Institution - 0172

    Barcelona, 08036

  • Local Institution - 0205

    Elche, Alicante, 03203

  • Local Institution - 0173

    Madrid, 28040

  • Local Institution - 0176

    Madrid, 28050

  • Local Institution - 0169

    Málaga, 29010

  • Local Institution - 0204

    Pamplona, 31008

  • Local Institution - 0174

    Santiago de Compostela, 15706

  • Local Institution - 0170

    Seville, 41013

  • Local Institution - 0175

    Valencia, 46010

Other trials in Spain

Australia8 sites

  • Local Institution - 0066

    Clayton, Victoria, 3168

  • Local Institution - 0142

    Clayton, Victoria, 3168

  • Local Institution - 0067

    Elizabeth Vale, South Australia, 5112

  • Local Institution - 0072

    Herston, Queensland, 4029

  • Local Institution - 0070

    Melbourne, Victoria, 3000

  • Local Institution - 0068

    North Ballarat, Victoria, 33500

  • Local Institution - 0071

    North Sydney, New South Wales, 2060

  • Local Institution - 0069

    Port Macquarie, New South Wales, 2444

Other trials in Australia

Colombia8 sites

  • Local Institution - 0261

    Barranquilla, Atlántico, 080020

  • Local Institution - 0094

    Bogotá, Bogota D.C., 110221

  • Local Institution - 0093

    Cali, 0

  • Local Institution - 0203

    Colombia, Bogota D.C., 0

  • Local Institution - 0113

    Montería, Departamento de Córdoba, 230002

  • Local Institution - 0271

    Pereira, 660004

  • Local Institution - 0098

    Piedecuesta, Santander Department, 681017

  • Local Institution - 0202

    Rionegro, 054047

Other trials in Colombia

Italy8 sites

  • Local Institution - 0191

    Catanzaro, 88100

  • Local Institution - 0207

    Milan, 20141

  • Azienda Ospedaliero Universitaria Federico II di Napoli

    Naples, 80131

  • Local Institution - 0124

    Naples, 80131

  • Local Institution - 0155

    Padova, 35128

  • Fondazione Irccs - Policlinico San Matteo

    Pavia, 27100

  • Local Institution - 0190

    Roma, 00128

  • Local Institution - 0125

    Rozzano (MI), 20089

Other trials in Italy

Russia8 sites

  • Local Institution

    Krasnodar, 350040

  • Local Institution - 0119

    Moscow, 115478

  • Local Institution

    Moscow, 125367

  • Local Institution - 0285

    Moskva, 111123

  • Local Institution

    Ryazan, 390011

  • Local Institution - 0306

    Saint Petersburg, 194107

  • Local Institution - 0284

    Saint Petersburg, 197758

  • Local Institution

    Sochi, 354057

Other trials in Russia

Poland7 sites

  • Local Institution - 0335

    Bydgoszcz, 85796

  • Local Institution - 0334

    Gliwice, Silesian Voivodeship, 44-102

  • Local Institution - 0061

    Koszalin, 75-581

  • Local Institution - 0059

    Krakow, 30-688

  • Local Institution - 0063

    Lodz, 93-338

  • Local Institution - 0062

    Opole, 45-061

  • Local Institution - 0060

    Warsaw, 02-781

Other trials in Poland

Chile6 sites

  • Local Institution - 0326

    Antofagasta

  • Local Institution - 0197

    La Serena, Coquimbo Region, 1720430

  • Local Institution - 0016

    Santiago, Santiago Metropolitan, 0

  • Local Institution - 0318

    Santiago, Santiago Metropolitan, 6900941

  • Local Institution - 0019

    Santiago Region Metropolitana, Santiago Metropolitan, 8330034

  • Local Institution - 0018

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

Romania6 sites

  • Local Institution - 0029

    Bucharest, 011171

  • Local Institution - 0025

    Bucharest, 022328

  • Local Institution - 0270

    Bucharest, 022328

  • Local Institution - 0028

    Craiova, 200542

  • Local Institution - 0027

    Floreşti, 407280

  • Local Institution - 0026

    Suceava, 720237

Other trials in Romania

Austria5 sites

  • Local Institution - 0045

    Graz, 8036

  • Local Institution - 0042

    Innsbruck, 6020

  • Local Institution - 0048

    Salzburg, 5020

  • Local Institution - 0046

    Vienna, 1090

  • Local Institution - 0047

    Vienna, 1090

Other trials in Austria

Belgium5 sites

  • Local Institution - 0187

    Brussels, 1090

  • Local Institution - 0030

    Charleroi, 6000

  • Local Institution - 0037

    Edegem, 2650

  • Local Institution - 0032

    Ghent, 9000

  • Local Institution - 0031

    Liège, 4000

Other trials in Belgium

South Korea5 sites

  • Local Institution - 0325

    Seongnam, 13620

  • Local Institution - 0295

    Seoul, 03080

  • Local Institution - 0320

    Seoul, 03722

  • Local Institution - 0290

    Seoul, 05505

  • Local Institution - 0291

    Seoul, 06351

Other trials in South Korea

Taiwan5 sites

  • Local Institution - 0301

    Kaohsiung City, 807

  • Local Institution - 0298

    Tainan, 70457

  • Local Institution - 0300

    Tainan, 71004

  • Local Institution - 0305

    Taipei, 10449

  • Local Institution - 0297

    Taipei, 11217

Other trials in Taiwan

Czechia4 sites

  • Local Institution - 0100

    Hradec Králové, 500 05

  • Local Institution - 0103

    Nový Jičín, 741 01

  • Local Institution - 0101

    Olomouc, 779 00

  • Local Institution - 0099

    Prague, 100 34

Other trials in Czechia

Denmark4 sites

  • Local Institution - 0167

    Aarhus N, Central Jutland, 8200

  • Local Institution - 0165

    Herlev, 2730

  • Local Institution - 0164

    København Ø, 2100

  • Local Institution - 0166

    Næstved, 4700

Other trials in Denmark

Netherlands4 sites

  • Local Institution - 0033

    Amsterdam, 1066 CX

  • Local Institution - 0177

    Breda, 4818CK

  • Local Institution - 0199

    Deventer, 7416 SE

  • Local Institution - 0147

    Utrecht, 3584 CX

Other trials in Netherlands

Turkey (Türkiye)4 sites

  • Local Institution - 0073

    Adana, 01060

  • Local Institution - 0257

    Ankara, 06520

  • Local Institution - 0075

    Antalya, 07070

  • Local Institution - 0074

    Istanbul, 34300

Other trials in Turkey (Türkiye)

Canada3 sites

  • Local Institution - 0095

    Montreal, Quebec, H2X 0C1

  • Local Institution - 0194

    Montreal, Quebec, H3T 1E2

  • Local Institution - 0058

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

Ireland3 sites

  • Local Institution - 0035

    Beaumont, Dublin 9

  • Local Institution - 0036

    Cork

  • Local Institution - 0034

    Dublin, Dublin

Other trials in Ireland

Portugal3 sites

  • Local Institution - 0210

    Lisbon, 1500-650

  • Local Institution - 0211

    Lisbon, 1649-035

  • Local Institution - 0209

    Porto, 4200

Other trials in Portugal

Singapore3 sites

  • Local Institution - 0078

    Singapore, 119228

  • Local Institution - 0076

    Singapore, 168583

  • Local Institution - 0077

    Singapore, 308442

Other trials in Singapore

Switzerland3 sites

  • Local Institution - 0184

    Basel, 4031

  • Local Institution - 0186

    Lausanne, 1011

  • Local Institution - 0185

    Thun, 3600

Other trials in Switzerland

Finland2 sites

  • Local Institution - 0001

    Helsinki, 00029

  • Local Institution - 0160

    Tampere, 33521

Other trials in Finland

United Kingdom2 sites

  • Local Institution - 0005

    London, NW1 2BU

  • Local Institution - 0006

    Withington, Manchester, M20 4BX

Other trials in United Kingdom

Hong Kong1 site

  • Local Institution - 0115

    Hong Kong, 0

Other trials in Hong Kong

Puerto Rico1 site

  • Local Institution - 0110

    Ponce, 00716-0200

Other trials in Puerto Rico

About this study

Official title: A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer

A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) early stage breast cancer.

Conditions
Breast Cancer
Being tested
nivolumab, paclitaxel (PTX), nivolumab placebo, anthracycline, cyclophosphamide
Keywords
Nivolumab, Breast Cancer, Cancer, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor 2 Negative (HER2-), Neoadjuvant, Adjuvant, Primary Breast Cancer
Medical subject headings
Breast Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nivolumabBiological

    Specified Dose on Specified days

  • paclitaxel (PTX)Drug

    Specified dose on Specified days

  • nivolumab placeboOther

    Specified dose on Specified days

  • anthracyclineDrug

    Specified dose on Specified days

  • cyclophosphamideDrug

    Specified dose on Specified days

  • Endocrine TherapyDrug

    Variable endocrine therapy of investigators choice

  • SurgeryProcedure or surgery

    Surgery for breast cancer

Study groups in NCT04109066
Study groupRoleWhat they receive
Arm A: Nivolumab combined with neoadjuvant CT and adjuvant ETExperimentalNivolumab with paclitaxel followed by nivolumab with anthracycline + cyclophosphamide as neoadjuvant (pre-surgery) treatment, then nivolumab with adjuvant (post-surgery) endocrine therapy of investigator's choice
Receives: Biological: nivolumab; Drug: paclitaxel (PTX); Drug: anthracycline; Drug: cyclophosphamide; Drug: Endocrine Therapy; Procedure: Surgery
Arm B: Placebo combined with neoadjuvant CT and then adjuvant ETPlacebo comparatorNivolumab placebo with paclitaxel followed by nivolumab placebo with anthracycline + cyclophosphamide as neoadjuvant (pre-surgery) treatment, then adjuvant (post-surgery) endocrine therapy of investigator's choice
Receives: Drug: paclitaxel (PTX); Other: nivolumab placebo; Drug: anthracycline; Drug: cyclophosphamide; Drug: Endocrine Therapy; Procedure: Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological Complete Response (pCR) Rate

    pCR rate is defined as the percentage of participants who achieved pCR. pCR is defined as no invasive residual disease in breast and lymph nodes performed by a local pathologist. Criteria for evaluation of pCR includes the following: pCR in breast, axillary lymph nodes and non-axillary sentinel node; no histologic evidence of invasive tumor cells; and pCR in the breast.

    Measured: Up to approximately 37 months

Secondary outcomes (6)

  1. Pathological Complete Response (pCR) Rate (PD-L1 >=1%)

    pCR rate is defined as the percentage of participants who achieved pCR. pCR is defined as no invasive residual disease in breast and lymph nodes performed by a local pathologist. Criteria for evaluation of pCR includes the following: pCR in breast, axillary lymph nodes and non-axillary sentinel node; no histologic evidence of invasive tumor cells; and pCR in the breast.

    Measured: Up to approximately 37 months

  2. Number of Participants With Residual Cancer Burden (RCB)

    RCB is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. RCB is categorized into the following 4 classes: RCB-0: no residual disease; RCB-1: minimal residual disease; RCB-II: moderate residual disease; RCB-III: and extensive residual disease.

    Measured: Up to approximately 37 months

  3. Number of Participants With Residual Cancer Burden (RCB) PD-L1 >=1%

    RCB is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. RCB is categorized into the following 4 classes: RCB-0: no residual disease; RCB-1: minimal residual disease; RCB-II: moderate residual disease; RCB-III: and extensive residual disease.

    Measured: Up to approximately 37 months

  4. Number of Participants With Adverse Events (AEs)

    Number of participants with any grade adverse events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relation with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: From first dose to 30 days post last dose of neoadjuvant or adjuvant study therapy (Up to approximately 19 months)

  5. Number of Participants With Serious Adverse Events (SAEs)

    Number of participants with any grade serious adverse events (SAE). SAE is defined as any untoward medical occurrence that, at any dose: Results in death; is life threatening; requires inpatient hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: From first dose to 30 days post last dose of neoadjuvant or adjuvant study therapy (Up to approximately 19 months)

  6. Number of Participants Who Died

    Number of participants who died due to any cause.

    Measured: Up to approximately 41 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2019
  2. Study start18 Nov 2019
  3. Primary completion16 Jan 2023
  4. Study completion27 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
521 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04109066
Sponsor's protocol ID
CA209-7FL
Acronym
CheckMate 7FL
Status last verified
Dec 2024
First submitted
27 Sep 2019
Last updated
8 Jan 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Expanded access
Available

Publications

  • Loi S, Salgado R, Curigliano G, Romero Diaz RI, Delaloge S, Rojas Garcia CI, Kok M, Saura C, Harbeck N, Mittendorf EA, Yardley DA, Suarez Zaizar A, Caminos FR, Ungureanu A, Reinoso-Toledo JG, Guarneri V, Egle D, Ades F, Pacius M, Chhibber A, Chandra R, Nathani R, Spires T, Wu JQ, Pusztai L, McArthur H. Neoadjuvant nivolumab and chemotherapy in early estrogen receptor-positive breast cancer: a randomized phase 3 trial. Nat Med. 2025 Feb;31(2):433-441. doi: 10.1038/s41591-024-03414-8. Epub 2025 Jan 21.

    PubMed 39838118

  • Schlam I, Corti C, Sammons S, Mittendorf EA, Tolaney SM. Checkpoint inhibition for early-stage hormone receptor-positive breast cancer. Expert Opin Biol Ther. 2024 Jun;24(6):511-520. doi: 10.1080/14712598.2024.2370395. Epub 2024 Jun 24.

    PubMed 38913933

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing nivolumab, paclitaxel (PTX) and anthracycline in people with Breast Cancer, run by Bristol-Myers Squibb at 240 sites in 32 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 240 sites in United States, China, Brazil, Germany, Argentina and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological Complete Response (pCR) Rate (time frame: Up to approximately 37 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04109066, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.

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