Triple-negative Breast CancerPhase 4NeoSTEPNCT05843292

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

A Phase 4 study testing Taxane and Carboplatin, Short-term Sintilimab and Surgery in people with Triple-negative Breast Cancer, run by Shanghai Jiao Tong University School of Medicine.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Triple-negative Breast Cancer
What is being tested?: Taxane and Carboplatin, Short-term Sintilimab and Surgery
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: No sites listed yet
Study dates: 1 Jul 2023to 31 Dec 2034
Phase: Phase 4
Are there results?: Not yet: the study is under way

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 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Show all 11Show fewer

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.

Who cannot join

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;

Show all 20Show fewer

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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Jiayi Wu contact

0086-021-64370045

pinkscorpio@163.com

About this study

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

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.

Conditions: Triple-negative Breast Cancer
Being tested: Taxane and Carboplatin, Short-term Sintilimab, Surgery
Keywords: Short-term Sintilimab, Taxane, Carboplatin, Neoadjuvant Therapy
Medical subject headings: Triple Negative Breast Neoplasms

What participants receive

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

Taxane and CarboplatinDrug
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.
Short-term SintilimabDrug
Sintilimab 200mg by intravenous (IV) infusion on day1, every 3 weeks, for 2 cycles.
SurgeryProcedure or surgery
All participants who are eligible for surgery will undergo surgery and have their pathologic response evaluated.

Study groups in NCT05843292
Study group	Role	What they receive
Short-term Sintilimab in Combination With Taxane and Carboplatin	Experimental	Prior to surgery: 2 cycles of sintilimab, in combination with 4 cycles of taxane and carboplatin Receives: Drug: Taxane and Carboplatin; Drug: Short-term Sintilimab; Procedure: Surgery

What is being measured

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

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).
Measured: At surgery.

Secondary outcomes (3)

Objective Response Rates (ORR)
The percentage of participants with complete response (CR) and partial response (PR) in accordance with RECIST V1.1 definitions.
Measured: At surgery.
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.
Measured: From Baseline to EFS event or date last known to be alive and event-free (up to 10 years)
Overall survival (OS)
OS was defined as the time from diagnosis to death from any cause.
Measured: Time Frame: From Baseline to OS event or date last known to be alive (up to 10 years)

Timeline

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

1 Jul 202331 Dec 2034

First posted6 May 2023
Study start1 Jul 2023 (estimated)
Primary completion31 Dec 2024 (estimated)
Study completion31 Dec 2034 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (28)Papers the sponsor has linked to this study.
Other trials for Triple-negative Breast CancerStudies of the same condition, open and under way.
More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 48 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05843292
Sponsor's protocol ID: NeoSTEP
Acronym: NeoSTEP
Status last verified: Jun 2023
First submitted: 25 Apr 2023
Last updated: 6 Jun 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 33538338
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.
PubMed 25043972
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.
PubMed 17329194
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.
PubMed 31282032
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.
PubMed 27184417
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.
PubMed 22508810
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.
PubMed 29348858
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.
PubMed 28740920
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.
PubMed 28710865
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.
PubMed 29501363
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.
PubMed 25092775
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.
PubMed 24794243
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.
PubMed 33208340
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.
PubMed 34591977
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.
PubMed 20211870

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05843292
Acronym / sponsor ID: NeoSTEP / NeoSTEP
Conditions: Triple-negative Breast Cancer
Keywords: Short-term Sintilimab, Taxane, Carboplatin, Neoadjuvant Therapy
Phase: Phase 4
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 48 participants (estimated)
Lead sponsor: Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
Collaborators: Innovent Biologics, Inc., CSPC Ouyi Pharmaceutical Co., Ltd.
Study start: 1 Jul 2023 (estimated)
Primary completion: 31 Dec 2024 (estimated)
Study completion: 31 Dec 2034 (estimated)
First posted: 6 May 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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?

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Short-term Sintilimab in Combination With Taxane and Carboplatin	Experimental	Drug: Taxane and Carboplatin, Drug: Short-term Sintilimab, Procedure: SurgeryPrior to surgery: 2 cycles of sintilimab, in combination with 4 cycles of taxane and carboplatin

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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;

Key exclusion criteria (20 listed)

Bilateral invasive breast cancer or metastatic (Stage IV) breast cancer;
With severe cardiovascular conditions:
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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Taxane and CarboplatinNab-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.	Drug	Short-term Sintilimab in Combination With Taxane and Carboplatin
Short-term SintilimabSintilimab 200mg by intravenous (IV) infusion on day1, every 3 weeks, for 2 cycles.	Drug	Short-term Sintilimab in Combination With Taxane and Carboplatin
SurgeryAll participants who are eligible for surgery will undergo surgery and have their pathologic response evaluated.	Procedure or surgery	Short-term Sintilimab in Combination With Taxane and Carboplatin

Primary outcome

Pathologic Complete Response (pCR) Rates
Time frame: At surgery.
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).

3 secondary outcomes

Objective Response Rates (ORR)
Time frame: At surgery.
Event-free survival (EFS)
Time frame: From Baseline to EFS event or date last known to be alive and event-free (up to 10 years)
Overall survival (OS)
Time frame: Time Frame: From Baseline to OS event or date last known to be alive (up to 10 years)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
Background: PubMed 33538338Sung 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.
Background: PubMed 25043972Abramson 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.
Background: PubMed 17329194Cleator 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.
Background: PubMed 31282032Scott 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.
Background: PubMed 27184417Bianchini 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.
Background: PubMed 22508810Schott 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.
Background: PubMed 29348858Biswas 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.
Background: PubMed 28740920Chen 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.
Background: PubMed 28710865Gamucci 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.
Background: PubMed 29501363Loibl 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.
Background: PubMed 25092775Sikov 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.
Background: PubMed 24794243von 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Jiayi Wu contact

0086-021-64370045

pinkscorpio@163.com

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Taxane and Carboplatin, Short-term Sintilimab and Surgery in people with Triple-negative Breast Cancer, run by Shanghai Jiao Tong University School of Medicine.

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 11 inclusion and 20 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: opening soon, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Jiayi Wu (0086-021-64370045, pinkscorpio@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic Complete Response (pCR) Rates (time frame: At surgery.). 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 NCT05843292, which also lists 28 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 6 Jun 2023.