search
Back to results

Short-term Sintilimab in Combination With Taxane and Carboplatin for Neoadjuvant Therapy in Triple-negative Breast Cancer (NeoSTEP)

Primary Purpose

Triple-negative Breast Cancer

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Taxane and Carboplatin
Short-term Sintilimab
Surgery
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triple-negative Breast Cancer focused on measuring Short-term Sintilimab, Taxane, Carboplatin, Neoadjuvant Therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Age: 18-70 years, female; Unilateral, invasive, primary breast cancer, T≥1cm, cN0-3, M0; Immunohistochemistry(IHC): ER, PR<10%; HER-2 IHC "0", OR IHC "+", OR IHC "++" AND fluorescence in situ hybridization (FISH) negative; At least one measurable lesion according to RECIST V1.1; Newly or recently-collected core needle biopsy specimen of the primary lesion available for PD-L1 status determination; ECOG score 0 or 1 within 10 days prior to drug administration; Currently not pregnant or breastfeeding, and meet at least one of the following conditions: NOT women of childbearing potential (WOCBPs). WOCBPs that strictly adopt contraceptive measures during treatment and within at least 6 months after last drug administration. Organs well-functioned according to laboratory examination and imaging; Having good compliance with treatment plans, being capable of understanding the research process, and having signed a written informed consent. Exclusion Criteria: Bilateral invasive breast cancer or metastatic (Stage IV) breast cancer; With severe cardiovascular conditions: Myocardial infarction, acute coronary syndrome or PCI/CABG within 6 months; Current NYHA II-IV congestive heart failure (CHF) or past history of NYHA III-IV CHF. Immunodeficiency, or undergoing systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to drug administration; Active autoimmune diseases requiring systemic treatment within the past 2 years; Known history of active tuberculosis caused by Bacillus Tuberculosis; History of non infectious pneumonia requiring steroid treatment, or active pneumonia of all types; Severe systemic infections, or other serious illnesses; History of other malignant tumors within the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer; Known history of human immunodeficiency virus (HIV) infection; Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; Known allergy or intolerance to therapeutic drugs or their excipients; History of receiving cytotoxic chemotherapy, endocrine therapy, biological therapy or radiation therapy for any reason; History of receiving anti PD-1, anti PD-L1, or anti PD-L2 drugs; or targeted drugs that act on stimulating or co-inhibitory T cell receptors (CTLA-4, OX 40, CD137 etc.); Enrolled in a study of an investigational drug/instrument and given intervention within 4 weeks prior to drug administration for regular drugs/instruments and within 12 months for anticancer or anti-proliferative drugs/instruments; Live vaccine (including but not limited to the following: measles, mumps, rubella, chickenpox/shingles, yellow fever, rabies, BCG, typhoid vaccines, and nasal influenza vaccines such as FluMist®) inoculation within 30 days prior to drug administration; History of mental illness or drug abuse that may affect compliance with trial requirements; During pregnancy or breastfeeding, or WOCABs that refuse to adopt strict contraceptive measures; Deemed to be not appropriate for participating in this study by researchers.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Short-term Sintilimab in Combination With Taxane and Carboplatin

    Arm Description

    Prior to surgery: 2 cycles of sintilimab, in combination with 4 cycles of taxane and carboplatin

    Outcomes

    Primary Outcome Measures

    Pathologic Complete Response (pCR) Rates
    The percentage of participants with the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes after completion of neoadjuvant therapy and surgery (that is, ypT0/is, ypN0, in accordance with the current American Joint Committee on Cancer [AJCC] staging system).

    Secondary Outcome Measures

    Objective Response Rates (ORR)
    The percentage of participants with complete response (CR) and partial response (PR) in accordance with RECIST V1.1 definitions.
    Event-free survival (EFS)
    EFS is defined as the time from diagnosis to the first documentation of one of the following events: Disease progression (before surgery) as determined by the investigator with use of RECIST V1.1. Disease recurrence (local, regional, or distant) after surgery. Contralateral breast cancer. Second primary tumor. Death from any cause.
    Overall survival (OS)
    OS was defined as the time from diagnosis to death from any cause.

    Full Information

    First Posted
    April 25, 2023
    Last Updated
    June 3, 2023
    Sponsor
    Shanghai Jiao Tong University School of Medicine
    Collaborators
    Innovent Biologics, Inc., CSPC Ouyi Pharmaceutical Co., Ltd.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05843292
    Brief Title
    Short-term Sintilimab in Combination With Taxane and Carboplatin for Neoadjuvant Therapy in Triple-negative Breast Cancer
    Acronym
    NeoSTEP
    Official Title
    Short-term Sintilimab in Combination With Taxane and Carboplatin for Neoadjuvant Therapy in Triple-negative Breast Cancer, an Open-labeled, Single Arm Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2034 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai Jiao Tong University School of Medicine
    Collaborators
    Innovent Biologics, Inc., CSPC Ouyi Pharmaceutical Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to learn about the efficacy and safety of short-term sintilimab in combination with taxane and carboplatin for neoadjuvant therapy in female early-stage triple-negative breast caner patients aging from 18 to 70 years with unilateral and invasive primary lesions above 1cm. The main questions it aims to answer are: Does short-term sintilimab in combination with taxane and carboplatin lead to acceptible pathological complete response (pCR) rates, objective response rates (ORR), event-free survival (EFS) and overall survival (OS)? Does short-term sintilimab in combination with taxane and carboplatin lead to less adverse events than regular-term ICIs reported in literature? Participants will be given 2 cycles of sintilimab, in combination with 4 cycles of taxane and carboplatin before surgery. An optional core-needle biopsy is performed after completing 2 cycles of sintilimab. All participants will be given regular follow-up post surgery according to ASCO guidelines.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Triple-negative Breast Cancer
    Keywords
    Short-term Sintilimab, Taxane, Carboplatin, Neoadjuvant Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    48 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Short-term Sintilimab in Combination With Taxane and Carboplatin
    Arm Type
    Experimental
    Arm Description
    Prior to surgery: 2 cycles of sintilimab, in combination with 4 cycles of taxane and carboplatin
    Intervention Type
    Drug
    Intervention Name(s)
    Taxane and Carboplatin
    Intervention Description
    Nab-paclitaxel 100mg/m2+ Carboplatin AUC2 by intravenous (IV) infusion on day1, day8 and day15, every 4 weeks, for 4 cycles. or Docetaxel 75mg/m2+ Carboplatin AUC5 by intravenous (IV) infusion on day1, every 3 weeks, for 4 cycles. or Paclitaxel 80mg/m2+ Carboplatin AUC2 by intravenous (IV) infusion on day1, day8 and day15, every 4 weeks, for 4 cycles.
    Intervention Type
    Drug
    Intervention Name(s)
    Short-term Sintilimab
    Intervention Description
    Sintilimab 200mg by intravenous (IV) infusion on day1, every 3 weeks, for 2 cycles.
    Intervention Type
    Procedure
    Intervention Name(s)
    Surgery
    Intervention Description
    All participants who are eligible for surgery will undergo surgery and have their pathologic response evaluated.
    Primary Outcome Measure Information:
    Title
    Pathologic Complete Response (pCR) Rates
    Description
    The percentage of participants with the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes after completion of neoadjuvant therapy and surgery (that is, ypT0/is, ypN0, in accordance with the current American Joint Committee on Cancer [AJCC] staging system).
    Time Frame
    At surgery.
    Secondary Outcome Measure Information:
    Title
    Objective Response Rates (ORR)
    Description
    The percentage of participants with complete response (CR) and partial response (PR) in accordance with RECIST V1.1 definitions.
    Time Frame
    At surgery.
    Title
    Event-free survival (EFS)
    Description
    EFS is defined as the time from diagnosis to the first documentation of one of the following events: Disease progression (before surgery) as determined by the investigator with use of RECIST V1.1. Disease recurrence (local, regional, or distant) after surgery. Contralateral breast cancer. Second primary tumor. Death from any cause.
    Time Frame
    From Baseline to EFS event or date last known to be alive and event-free (up to 10 years)
    Title
    Overall survival (OS)
    Description
    OS was defined as the time from diagnosis to death from any cause.
    Time Frame
    Time Frame: From Baseline to OS event or date last known to be alive (up to 10 years)
    Other Pre-specified Outcome Measures:
    Title
    Percentage of Participants With At Least One Adverse Event During Treatment Period
    Description
    The percentage of participants who experienced at least one adverse event during study treatment.
    Time Frame
    From randomization to 30 days after completion of study treatment

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age: 18-70 years, female; Unilateral, invasive, primary breast cancer, T≥1cm, cN0-3, M0; Immunohistochemistry(IHC): ER, PR<10%; HER-2 IHC "0", OR IHC "+", OR IHC "++" AND fluorescence in situ hybridization (FISH) negative; At least one measurable lesion according to RECIST V1.1; Newly or recently-collected core needle biopsy specimen of the primary lesion available for PD-L1 status determination; ECOG score 0 or 1 within 10 days prior to drug administration; Currently not pregnant or breastfeeding, and meet at least one of the following conditions: NOT women of childbearing potential (WOCBPs). WOCBPs that strictly adopt contraceptive measures during treatment and within at least 6 months after last drug administration. Organs well-functioned according to laboratory examination and imaging; Having good compliance with treatment plans, being capable of understanding the research process, and having signed a written informed consent. Exclusion Criteria: Bilateral invasive breast cancer or metastatic (Stage IV) breast cancer; With severe cardiovascular conditions: Myocardial infarction, acute coronary syndrome or PCI/CABG within 6 months; Current NYHA II-IV congestive heart failure (CHF) or past history of NYHA III-IV CHF. Immunodeficiency, or undergoing systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to drug administration; Active autoimmune diseases requiring systemic treatment within the past 2 years; Known history of active tuberculosis caused by Bacillus Tuberculosis; History of non infectious pneumonia requiring steroid treatment, or active pneumonia of all types; Severe systemic infections, or other serious illnesses; History of other malignant tumors within the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer; Known history of human immunodeficiency virus (HIV) infection; Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; Known allergy or intolerance to therapeutic drugs or their excipients; History of receiving cytotoxic chemotherapy, endocrine therapy, biological therapy or radiation therapy for any reason; History of receiving anti PD-1, anti PD-L1, or anti PD-L2 drugs; or targeted drugs that act on stimulating or co-inhibitory T cell receptors (CTLA-4, OX 40, CD137 etc.); Enrolled in a study of an investigational drug/instrument and given intervention within 4 weeks prior to drug administration for regular drugs/instruments and within 12 months for anticancer or anti-proliferative drugs/instruments; Live vaccine (including but not limited to the following: measles, mumps, rubella, chickenpox/shingles, yellow fever, rabies, BCG, typhoid vaccines, and nasal influenza vaccines such as FluMist®) inoculation within 30 days prior to drug administration; History of mental illness or drug abuse that may affect compliance with trial requirements; During pregnancy or breastfeeding, or WOCABs that refuse to adopt strict contraceptive measures; Deemed to be not appropriate for participating in this study by researchers.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jiayi Wu
    Phone
    0086-021-64370045
    Email
    pinkscorpio@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33538338
    Citation
    Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
    Results Reference
    background
    PubMed Identifier
    25043972
    Citation
    Abramson VG, Lehmann BD, Ballinger TJ, Pietenpol JA. Subtyping of triple-negative breast cancer: implications for therapy. Cancer. 2015 Jan 1;121(1):8-16. doi: 10.1002/cncr.28914. Epub 2014 Jul 16.
    Results Reference
    background
    PubMed Identifier
    17329194
    Citation
    Cleator S, Heller W, Coombes RC. Triple-negative breast cancer: therapeutic options. Lancet Oncol. 2007 Mar;8(3):235-44. doi: 10.1016/S1470-2045(07)70074-8.
    Results Reference
    background
    PubMed Identifier
    31282032
    Citation
    Scott LC, Mobley LR, Kuo TM, Il'yasova D. Update on triple-negative breast cancer disparities for the United States: A population-based study from the United States Cancer Statistics database, 2010 through 2014. Cancer. 2019 Oct 1;125(19):3412-3417. doi: 10.1002/cncr.32207. Epub 2019 Jul 8.
    Results Reference
    background
    PubMed Identifier
    27184417
    Citation
    Bianchini G, Balko JM, Mayer IA, Sanders ME, Gianni L. Triple-negative breast cancer: challenges and opportunities of a heterogeneous disease. Nat Rev Clin Oncol. 2016 Nov;13(11):674-690. doi: 10.1038/nrclinonc.2016.66. Epub 2016 May 17.
    Results Reference
    background
    PubMed Identifier
    22508810
    Citation
    Schott AF, Hayes DF. Defining the benefits of neoadjuvant chemotherapy for breast cancer. J Clin Oncol. 2012 May 20;30(15):1747-9. doi: 10.1200/JCO.2011.41.3161. Epub 2012 Apr 16. No abstract available.
    Results Reference
    background
    PubMed Identifier
    29348858
    Citation
    Biswas T, Efird JT, Prasad S, Jindal C, Walker PR. The survival benefit of neoadjuvant chemotherapy and pCR among patients with advanced stage triple negative breast cancer. Oncotarget. 2017 Nov 20;8(68):112712-112719. doi: 10.18632/oncotarget.22521. eCollection 2017 Dec 22.
    Results Reference
    background
    PubMed Identifier
    28740920
    Citation
    Chen VE, Gillespie EF, Zakeri K, Murphy JD, Yashar CM, Lu S, Einck JP. Pathologic response after neoadjuvant chemotherapy predicts locoregional control in patients with triple negative breast cancer. Adv Radiat Oncol. 2017 Feb 7;2(2):105-109. doi: 10.1016/j.adro.2017.01.012. eCollection 2017 Apr-Jun.
    Results Reference
    background
    PubMed Identifier
    28710865
    Citation
    Gamucci T, Pizzuti L, Sperduti I, Mentuccia L, Vaccaro A, Moscetti L, Marchetti P, Carbognin L, Michelotti A, Iezzi L, Cassano A, Grassadonia A, Astone A, Botticelli A, Magnolfi E, Di Lauro L, Sergi D, Fuso P, Tinari N, Barba M, Maugeri-Sacca M, Landucci E, Conti F, Sanguineti G, De Tursi M, Iafrate G, Giordano A, Ciliberto G, Natoli C, Vici P. Neoadjuvant chemotherapy in triple-negative breast cancer: A multicentric retrospective observational study in real-life setting. J Cell Physiol. 2018 Mar;233(3):2313-2323. doi: 10.1002/jcp.26103. Epub 2017 Sep 27.
    Results Reference
    background
    PubMed Identifier
    29501363
    Citation
    Loibl S, O'Shaughnessy J, Untch M, Sikov WM, Rugo HS, McKee MD, Huober J, Golshan M, von Minckwitz G, Maag D, Sullivan D, Wolmark N, McIntyre K, Ponce Lorenzo JJ, Metzger Filho O, Rastogi P, Symmans WF, Liu X, Geyer CE Jr. Addition of the PARP inhibitor veliparib plus carboplatin or carboplatin alone to standard neoadjuvant chemotherapy in triple-negative breast cancer (BrighTNess): a randomised, phase 3 trial. Lancet Oncol. 2018 Apr;19(4):497-509. doi: 10.1016/S1470-2045(18)30111-6. Epub 2018 Feb 28.
    Results Reference
    background
    PubMed Identifier
    25092775
    Citation
    Sikov WM, Berry DA, Perou CM, Singh B, Cirrincione CT, Tolaney SM, Kuzma CS, Pluard TJ, Somlo G, Port ER, Golshan M, Bellon JR, Collyar D, Hahn OM, Carey LA, Hudis CA, Winer EP. Impact of the addition of carboplatin and/or bevacizumab to neoadjuvant once-per-week paclitaxel followed by dose-dense doxorubicin and cyclophosphamide on pathologic complete response rates in stage II to III triple-negative breast cancer: CALGB 40603 (Alliance). J Clin Oncol. 2015 Jan 1;33(1):13-21. doi: 10.1200/JCO.2014.57.0572. Epub 2014 Aug 4.
    Results Reference
    background
    PubMed Identifier
    24794243
    Citation
    von Minckwitz G, Schneeweiss A, Loibl S, Salat C, Denkert C, Rezai M, Blohmer JU, Jackisch C, Paepke S, Gerber B, Zahm DM, Kummel S, Eidtmann H, Klare P, Huober J, Costa S, Tesch H, Hanusch C, Hilfrich J, Khandan F, Fasching PA, Sinn BV, Engels K, Mehta K, Nekljudova V, Untch M. Neoadjuvant carboplatin in patients with triple-negative and HER2-positive early breast cancer (GeparSixto; GBG 66): a randomised phase 2 trial. Lancet Oncol. 2014 Jun;15(7):747-56. doi: 10.1016/S1470-2045(14)70160-3. Epub 2014 Apr 30.
    Results Reference
    background
    PubMed Identifier
    33208340
    Citation
    Sharma P, Kimler BF, O'Dea A, Nye L, Wang YY, Yoder R, Staley JM, Prochaska L, Wagner J, Amin AL, Larson K, Balanoff C, Elia M, Crane G, Madhusudhana S, Hoffmann M, Sheehan M, Rodriguez R, Finke K, Shah R, Satelli D, Shrestha A, Beck L, McKittrick R, Pluenneke R, Raja V, Beeki V, Corum L, Heldstab J, LaFaver S, Prager M, Phadnis M, Mudaranthakam DP, Jensen RA, Godwin AK, Salgado R, Mehta K, Khan Q. Randomized Phase II Trial of Anthracycline-free and Anthracycline-containing Neoadjuvant Carboplatin Chemotherapy Regimens in Stage I-III Triple-negative Breast Cancer (NeoSTOP). Clin Cancer Res. 2021 Feb 15;27(4):975-982. doi: 10.1158/1078-0432.CCR-20-3646. Epub 2020 Nov 18.
    Results Reference
    background
    PubMed Identifier
    34591977
    Citation
    Zhang L, Wu ZY, Li J, Lin Y, Liu Z, Cao Y, Zhang G, Gao HF, Yang M, Yang CQ, Zhu T, Cheng MY, Ji F, Li J, Wang K. Neoadjuvant docetaxel plus carboplatin vs epirubicin plus cyclophosphamide followed by docetaxel in triple-negative, early-stage breast cancer (NeoCART): Results from a multicenter, randomized controlled, open-label phase II trial. Int J Cancer. 2022 Feb 15;150(4):654-662. doi: 10.1002/ijc.33830. Epub 2021 Oct 7.
    Results Reference
    background
    PubMed Identifier
    20211870
    Citation
    Chen XS, Nie XQ, Chen CM, Wu JY, Wu J, Lu JS, Shao ZM, Shen ZZ, Shen KW. Weekly paclitaxel plus carboplatin is an effective nonanthracycline-containing regimen as neoadjuvant chemotherapy for breast cancer. Ann Oncol. 2010 May;21(5):961-7. doi: 10.1093/annonc/mdq041. Epub 2010 Mar 8.
    Results Reference
    background
    PubMed Identifier
    20636820
    Citation
    Francisco LM, Sage PT, Sharpe AH. The PD-1 pathway in tolerance and autoimmunity. Immunol Rev. 2010 Jul;236:219-42. doi: 10.1111/j.1600-065X.2010.00923.x.
    Results Reference
    background
    PubMed Identifier
    26137403
    Citation
    Buque A, Bloy N, Aranda F, Castoldi F, Eggermont A, Cremer I, Fridman WH, Fucikova J, Galon J, Marabelle A, Spisek R, Tartour E, Zitvogel L, Kroemer G, Galluzzi L. Trial Watch: Immunomodulatory monoclonal antibodies for oncological indications. Oncoimmunology. 2015 Mar 2;4(4):e1008814. doi: 10.1080/2162402X.2015.1008814. eCollection 2015 Apr.
    Results Reference
    background
    PubMed Identifier
    29208439
    Citation
    Syn NL, Teng MWL, Mok TSK, Soo RA. De-novo and acquired resistance to immune checkpoint targeting. Lancet Oncol. 2017 Dec;18(12):e731-e741. doi: 10.1016/S1470-2045(17)30607-1.
    Results Reference
    background
    PubMed Identifier
    22437870
    Citation
    Pardoll DM. The blockade of immune checkpoints in cancer immunotherapy. Nat Rev Cancer. 2012 Mar 22;12(4):252-64. doi: 10.1038/nrc3239.
    Results Reference
    background
    PubMed Identifier
    32623044
    Citation
    Gaynor N, Crown J, Collins DM. Immune checkpoint inhibitors: Key trials and an emerging role in breast cancer. Semin Cancer Biol. 2022 Feb;79:44-57. doi: 10.1016/j.semcancer.2020.06.016. Epub 2020 Jul 2.
    Results Reference
    background
    PubMed Identifier
    29899661
    Citation
    Makhoul I, Atiq M, Alwbari A, Kieber-Emmons T. Breast Cancer Immunotherapy: An Update. Breast Cancer (Auckl). 2018 May 30;12:1178223418774802. doi: 10.1177/1178223418774802. eCollection 2018.
    Results Reference
    background
    PubMed Identifier
    25993181
    Citation
    Disis ML, Stanton SE. Triple-negative breast cancer: immune modulation as the new treatment paradigm. Am Soc Clin Oncol Educ Book. 2015:e25-30. doi: 10.14694/EdBook_AM.2015.35.e25.
    Results Reference
    background
    PubMed Identifier
    24764583
    Citation
    Mittendorf EA, Philips AV, Meric-Bernstam F, Qiao N, Wu Y, Harrington S, Su X, Wang Y, Gonzalez-Angulo AM, Akcakanat A, Chawla A, Curran M, Hwu P, Sharma P, Litton JK, Molldrem JJ, Alatrash G. PD-L1 expression in triple-negative breast cancer. Cancer Immunol Res. 2014 Apr;2(4):361-70. doi: 10.1158/2326-6066.CIR-13-0127. Epub 2014 Jan 10.
    Results Reference
    background
    PubMed Identifier
    32101663
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    35139274
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    32966830
    Citation
    Mittendorf EA, Zhang H, Barrios CH, Saji S, Jung KH, Hegg R, Koehler A, Sohn J, Iwata H, Telli ML, Ferrario C, Punie K, Penault-Llorca F, Patel S, Duc AN, Liste-Hermoso M, Maiya V, Molinero L, Chui SY, Harbeck N. Neoadjuvant atezolizumab in combination with sequential nab-paclitaxel and anthracycline-based chemotherapy versus placebo and chemotherapy in patients with early-stage triple-negative breast cancer (IMpassion031): a randomised, double-blind, phase 3 trial. Lancet. 2020 Oct 10;396(10257):1090-1100. doi: 10.1016/S0140-6736(20)31953-X. Epub 2020 Sep 20.
    Results Reference
    background
    PubMed Identifier
    35182721
    Citation
    Gianni L, Huang CS, Egle D, Bermejo B, Zamagni C, Thill M, Anton A, Zambelli S, Bianchini G, Russo S, Ciruelos EM, Greil R, Semiglazov V, Colleoni M, Kelly C, Mariani G, Del Mastro L, Maffeis I, Valagussa P, Viale G. Pathologic complete response (pCR) to neoadjuvant treatment with or without atezolizumab in triple-negative, early high-risk and locally advanced breast cancer: NeoTRIP Michelangelo randomized study. Ann Oncol. 2022 May;33(5):534-543. doi: 10.1016/j.annonc.2022.02.004. Epub 2022 Feb 17.
    Results Reference
    background
    PubMed Identifier
    31095287
    Citation
    Loibl S, Untch M, Burchardi N, Huober J, Sinn BV, Blohmer JU, Grischke EM, Furlanetto J, Tesch H, Hanusch C, Engels K, Rezai M, Jackisch C, Schmitt WD, von Minckwitz G, Thomalla J, Kummel S, Rautenberg B, Fasching PA, Weber K, Rhiem K, Denkert C, Schneeweiss A. A randomised phase II study investigating durvalumab in addition to an anthracycline taxane-based neoadjuvant therapy in early triple-negative breast cancer: clinical results and biomarker analysis of GeparNuevo study. Ann Oncol. 2019 Aug 1;30(8):1279-1288. doi: 10.1093/annonc/mdz158. Erratum In: Ann Oncol. 2022 Jul;33(7):743-744.
    Results Reference
    background

    Learn more about this trial

    Short-term Sintilimab in Combination With Taxane and Carboplatin for Neoadjuvant Therapy in Triple-negative Breast Cancer

    We'll reach out to this number within 24 hrs