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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03036488




Registration number
NCT03036488
Ethics application status
Date submitted
27/01/2017
Date registered
30/01/2017
Date last updated
12/11/2024

Titles & IDs
Public title
Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522)
Scientific title
A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC)
Secondary ID [1] 0 0
173567
Secondary ID [2] 0 0
3475-522
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Triple Negative Breast Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Pembrolizumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Epirubicin
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Placebo
Treatment: Other - Granulocyte colony stimulating factor: Filgrastim or Pegfilgastrim

Experimental: Pembrolizumab + Chemotherapy - Participants receive pembrolizumab every 3 weeks (Q3W) + paclitaxel weekly + carboplatin (weekly or Q3W) x 4 cycles, followed by pembrolizumab Q3W + (doxorubicin OR epirubicin) + cyclophosphamide Q3W x 4 cycles as neoadjuvant therapy prior to surgery; followed by 9 cycles of pembrolizumab Q3W as adjuvant therapy post-surgery. Each cycle is 21 days.

Active comparator: Placebo + Chemotherapy - Participants receive placebo (normal saline solution) Q3W + paclitaxel weekly + carboplatin (weekly or Q3W) x 4 cycles, followed by placebo + (doxorubicin OR epirubicin) + cyclophosphamide Q3W x 4 cycles as neoadjuvant therapy prior to surgery; followed by 9 cycles of placebo Q3W as adjuvant therapy post-surgery. Each cycle is 21 days.


Treatment: Other: Pembrolizumab
On Day 1 of each cycle in the neoadjuvant and adjuvant phases of the study for a total of 17 cycles; intravenous (IV) infusion.

Treatment: Drugs: Carboplatin
On Day 1 of Cycles 1-4 of the neoadjuvant phase of the study OR on Days 1, 8, 15 of Cycles 1-4 of the neoadjuvant phase of the study; IV infusion.

Treatment: Drugs: Paclitaxel
On Days 1, 8 and 15 of Cycles 1-4 in the neoadjuvant phase of the study; IV infusion.

Treatment: Drugs: Doxorubicin
On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV injection.

Treatment: Drugs: Epirubicin
On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV injection.

Treatment: Drugs: Cyclophosphamide
On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV infusion.

Treatment: Drugs: Placebo
normal saline solution or dextrose: On Day 1 of each cycle in the neoadjuvant and adjuvant phases of the study for a total of 17 cycles; IV infusion

Treatment: Other: Granulocyte colony stimulating factor: Filgrastim or Pegfilgastrim
For prevention of neutropenia, filgrastim 5 µg/kg/day via subcutaneous (SC) injection administered per standard of care after chemotherapy OR pegfilgastrim 100 µg/kg (individualized) or 6 mg (general approach) via SC injection administered per standard of care.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery
Timepoint [1] 0 0
Up to approximately 27-30 weeks
Primary outcome [2] 0 0
Event-free Survival (EFS) as assessed by Investigator
Timepoint [2] 0 0
Up to approximately 8 years
Secondary outcome [1] 0 0
pCR rate using an alternative definition, ypT0 ypN0 (i.e., no invasive or noninvasive residual in breast or nodes) at the time of definitive surgery
Timepoint [1] 0 0
Up to approximately 27-30 weeks
Secondary outcome [2] 0 0
pCR rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery
Timepoint [2] 0 0
Up to approximately 27-30 weeks
Secondary outcome [3] 0 0
EFS in participants with tumors expressing PD-L1
Timepoint [3] 0 0
Up to approximately 8 years
Secondary outcome [4] 0 0
pCR rate using an alternative definition, ypT0/Tis (i.e., absence of invasive cancer in the breast irrespective of ductal carcinoma in situ or nodal involvement) at the time of definitive surgery
Timepoint [4] 0 0
Up to approximately 27-30 weeks
Secondary outcome [5] 0 0
Overall survival (OS)
Timepoint [5] 0 0
Up to approximately 8 years
Secondary outcome [6] 0 0
Percentage of participants who experience an adverse event (AE)
Timepoint [6] 0 0
Up to approximately 61 weeks
Secondary outcome [7] 0 0
Percentage of participants who discontinue study treatment due to an AE
Timepoint [7] 0 0
Up to approximately 57 weeks
Secondary outcome [8] 0 0
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Core 30 Questionnaire (QLQ-C30) score
Timepoint [8] 0 0
Up to approximately 27-30 weeks
Secondary outcome [9] 0 0
EORTC Breast Cancer-Specific QoL Questionnaire (QLQ-BR23) score
Timepoint [9] 0 0
Up to approximately 27-30 weeks

Eligibility
Key inclusion criteria
* Has newly diagnosed, locally advanced, centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
* Has previously untreated locally advanced non-metastatic (M0) TNBC defined as the following combined primary tumor (T) and regional lymph node (N) staging per current American Joint Committee of Cancer (AJCC) staging criteria for breast cancer as assessed by the investigator based on radiological and/or clinical assessment:

* T1c, N1-N2
* T2, N0-N2
* T3, N0-N2
* T4a-d, N0-N2
* Provides a core needle biopsy consisting of at least 2 separate tumor cores from the primary tumor at screening to the central laboratory.
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days of treatment initiation.
* Demonstrates adequate organ function.
* Males and female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 12 months after the last dose of study treatment for participants who have received cyclophosphamide, and 6 months after the last dose of study treatment for participants who did not.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has a history of invasive malignancy =5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
* Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months.
* Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death - ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated antigen-4 [CTLA-4], OX-40, CD137 [tumor necrosis factor receptor superfamily member 9 (TNFRSF9)]) or has previously participated in a pembrolizumab (MK-3475) clinical study.
* Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 4 weeks of the first dose of treatment in this current study.
* Has received a live vaccine within 30 days of the first dose of study treatment.
* Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (i.e., dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
* Has a known history of Human Immunodeficiency Virus (HIV).
* Has known active Hepatitis B or Hepatitis C.
* Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
* Has an active infection requiring systemic therapy.
* Has significant cardiovascular disease, such as: history of myocardial infarction, acute coronary syndrome or coronary angioplasty/stenting/bypass grafting within the last 6 months OR congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA Class III or IV.
* Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the screening visit through 12 months after the last dose of study treatment for participants who have received cyclophosphamide, and for 6 months after the last dose of study treatment for participants who have not.
* Has a known hypersensitivity to the components of the study treatment or its analogs.
* Has a known history of active tuberculosis (TB, Bacillus Tuberculosis).

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
Accrual to date
Final
1174
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Royal North Shore Hospital ( Site 2000) - Sydney
Recruitment hospital [2] 0 0
Westmead Hospital ( Site 2002) - Sydney
Recruitment hospital [3] 0 0
Royal Adelaide Hospital ( Site 2008) - Adelaide
Recruitment hospital [4] 0 0
Cabrini Health ( Site 2009) - East Malvern
Recruitment hospital [5] 0 0
Frankston Hospital ( Site 2010) - Franskton
Recruitment hospital [6] 0 0
Royal Brisbane and Women s Hospital ( Site 2003) - Herston
Recruitment hospital [7] 0 0
St John of God Subiaco Hospital ( Site 2006) - Perth
Recruitment postcode(s) [1] 0 0
2065 - Sydney
Recruitment postcode(s) [2] 0 0
2145 - Sydney
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3145 - East Malvern
Recruitment postcode(s) [5] 0 0
3199 - Franskton
Recruitment postcode(s) [6] 0 0
4029 - Herston
Recruitment postcode(s) [7] 0 0
6008 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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Colorado
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Connecticut
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Delaware
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Florida
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Illinois
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Indiana
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Iowa
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Maine
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Michigan
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Minnesota
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New Jersey
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New York
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Ohio
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Oregon
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Pennsylvania
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Rhode Island
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Tennessee
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Texas
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United States of America
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Virginia
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Washington
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Rio Grande Do Sul
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Cascavel
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Caxias do Sul
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Curitiba
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Fortaleza
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Goiania
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Porto Alegre
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Brazil
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Sao Jose do Rio Preto
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Brazil
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Sao Paulo
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Alberta
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Ontario
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Cordoba
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Risaralda
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Colombia
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Bogota
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Cali
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Colombia
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Medellin
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Le Mans
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Nantes
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Poitiers
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Toulouse Cedex 9
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Berlin
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Bonn
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Erlangen
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Essen
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Halle
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Hamburg
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Saarbruecken
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Tubingen
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Ireland
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Cork
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Ireland
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Dublin
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Israel
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Beer Sheva
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Israel
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Beer Yaakov-Zerifin
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Israel
State/province [62] 0 0
Jerusalem
Country [63] 0 0
Israel
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Petah Tikva
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Israel
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Ramat-Gan
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Israel
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Tel Aviv
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Italy
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FC
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Italy
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Brescia
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Italy
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Lucca
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Italy
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Macerata
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Italy
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Milano
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Italy
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Napoli
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Japan
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Aichi
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Chiba
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Hokkaido
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Hyogo
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Japan
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Kanagawa
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Shizuoka
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Japan
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Hiroshima
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Japan
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Kagoshima
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Japan
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Kumamoto
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Japan
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Tokyo
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Korea, Republic of
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Seoul
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Poland
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Mazowieckie
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Poland
State/province [86] 0 0
Slaskie
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Poland
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Bydgoszcz
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Poland
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Gdynia
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Poland
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Krakow
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Poland
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Lublin
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Poland
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Wroclaw
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Portugal
State/province [92] 0 0
Lisboa
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Portugal
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Porto
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Russian Federation
State/province [94] 0 0
Arkhangelsk
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Russian Federation
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Chelyabinsk
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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Ryazan
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Russian Federation
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Saint Petersburg
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Russian Federation
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Ufa
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Singapore
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Singapore
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Cordoba
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Spain
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Santiago de Compostela
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Spain
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Sevilla
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Spain
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Valencia
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Sweden
State/province [108] 0 0
Linkoping
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Sweden
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Solna
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Sweden
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Umea
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Sweden
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Uppsala
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Taiwan
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Beitou
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Turkey
State/province [116] 0 0
Atakum
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Turkey
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Adana
Country [118] 0 0
Turkey
State/province [118] 0 0
Ankara
Country [119] 0 0
Turkey
State/province [119] 0 0
Antalya
Country [120] 0 0
Turkey
State/province [120] 0 0
Edirne
Country [121] 0 0
Turkey
State/province [121] 0 0
Istambul
Country [122] 0 0
Turkey
State/province [122] 0 0
Istanbul
Country [123] 0 0
Turkey
State/province [123] 0 0
Izmir
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Essex
Country [125] 0 0
United Kingdom
State/province [125] 0 0
London
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Maidstone
Country [127] 0 0
United Kingdom
State/province [127] 0 0
Middlesbrough
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United Kingdom
State/province [128] 0 0
Nottingham
Country [129] 0 0
United Kingdom
State/province [129] 0 0
Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs placebo as adjuvant therapy in participants who have triple negative breast cancer (TNBC).

After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (Pembrolizumab + Chemotherapy OR Placebo + Chemotherapy) based on the randomization schedule for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment. After definitive surgery, each participant will receive adjuvant study treatment (Pembrolizumab OR Placebo) for approximately 27 weeks (9 cycles). Following adjuvant study treatment, each participant will be monitored for safety, survival and disease recurrence.

The primary study hypothesis is that pembrolizumab is superior to placebo, in combination with chemotherapy, as measured by the rate of Pathological Complete Response (pCR) and/or Event-free Survival (EFS), in participants with locally advanced TNBC.
Trial website
https://clinicaltrials.gov/study/NCT03036488
Trial related presentations / publications
Schmid P, Cortes J, Dent R, McArthur H, Pusztai L, Kummel S, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Im SA, Untch M, Fasching PA, Mouret-Reynier MA, Foukakis T, Ferreira M, Cardoso F, Zhou X, Karantza V, Tryfonidis K, Aktan G, O'Shaughnessy J; KEYNOTE-522 Investigators. Overall Survival with Pembrolizumab in Early-Stage Triple-Negative Breast Cancer. N Engl J Med. 2024 Sep 15. doi: 10.1056/NEJMoa2409932. Online ahead of print.
Schmid P, Cortes J, Dent R, Pusztai L, McArthur H, Kummel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Untch M, Fasching PA, Cardoso F, Andersen J, Patt D, Danso M, Ferreira M, Mouret-Reynier MA, Im SA, Ahn JH, Gion M, Baron-Hay S, Boileau JF, Ding Y, Tryfonidis K, Aktan G, Karantza V, O'Shaughnessy J; KEYNOTE-522 Investigators. Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer. N Engl J Med. 2022 Feb 10;386(6):556-567. doi: 10.1056/NEJMoa2112651.
Perez-Garcia J, Soberino J, Racca F, Gion M, Stradella A, Cortes J. Atezolizumab in the treatment of metastatic triple-negative breast cancer. Expert Opin Biol Ther. 2020 Sep;20(9):981-989. doi: 10.1080/14712598.2020.1769063. Epub 2020 May 25.
Schmid P, Cortes J, Pusztai L, McArthur H, Kummel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Foukakis T, Fasching PA, Cardoso F, Untch M, Jia L, Karantza V, Zhao J, Aktan G, Dent R, O'Shaughnessy J; KEYNOTE-522 Investigators. Pembrolizumab for Early Triple-Negative Breast Cancer. N Engl J Med. 2020 Feb 27;382(9):810-821. doi: 10.1056/NEJMoa1910549.
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03036488