Evidence map›Paper›PMID 39442958›Full record

Trial reportBMJ (Clinical research ed.)2024

Intensive chemotherapy versus standard chemotherapy among patients with high risk, operable, triple negative breast cancer based on integrated mRNA-lncRNA signature (BCTOP-T-A01): randomised, multicentre, phase 3 trial.

Min He, Yi-Zhou Jiang, Yue Gong, Lei Fan, Xi-Yu Liu, Yin Liu, Li-Chen Tang, Miao Mo, Yi-Feng Hou, Gen-Hong Di and 12 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ (Clinical research ed.), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02641847 (Efficacy and Safety Study of TA), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02641847 phase2 / phase3active not recruitingnot on this map

Efficacy and Safety Study of TA(E)C-GP Versus A(E)C-T for the High Risk Triple-negative Breast Cancer Patients Predicted by the Messenger RNA (mRNA)-Long Non-coding RNA (lncRNA) Signature and Validation of the Signature's Efficacy

TypeinterventionalSponsorFudan UniversityRan2016 to 2027Enrolled503ConditionsTriple Negative Breast Cancer, Breast CancerArmsdocetaxel, doxorubicin or epirubicin, cyclophosphamide, gemcitabine, cisplatin
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Article
  6. Epidemiology, early detection, and management of breast cancer in China: A comprehensive review.Chinese journal of cancer research = Chung-kuo yen cheng yen chiu · 2025
    Article
  7. Review
  8. Review
  9. Serum metabolic patterns reveal the diagnostic and prognostic role of alanine abnormality in ocular adnexal lymphoma.Proceedings of the National Academy of Sciences of the United States of America · 2025
    Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Recent advances in systematic therapy of breast cancer: Chinese contribution for international progress.Chinese journal of cancer research = Chung-kuo yen cheng yen chiu · 2024
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Min HeDepartment of Breast Surgery, Fudan University Shanghai Cancer and Key Laboratory of Breast Cancer in Shanghai, Shanghai, China.
Yi-Zhou JiangDepartment of Breast Surgery, Fudan University Shanghai Cancer and Key Laboratory of Breast Cancer in Shanghai, Shanghai, China.
Yue GongDepartment of Breast Surgery, Fudan University Shanghai Cancer and Key Laboratory of Breast Cancer in Shanghai, Shanghai, China.
Lei FanDepartment of Breast Surgery, Fudan University Shanghai Cancer and Key Laboratory of Breast Cancer in Shanghai, Shanghai, China.
Xi-Yu LiuDepartment of Breast Surgery, Fudan University Shanghai Cancer and Key Laboratory of Breast Cancer in Shanghai, Shanghai, China.
Yin LiuDepartment of Breast Surgery, Fudan University Shanghai Cancer and Key Laboratory of Breast Cancer in Shanghai, Shanghai, China.
Li-Chen TangDepartment of Breast Surgery, Fudan University Shanghai Cancer and Key Laboratory of Breast Cancer in Shanghai, Shanghai, China.
Miao MoDepartment of Breast Surgery, Fudan University Shanghai Cancer and Key Laboratory of Breast Cancer in Shanghai, Shanghai, China.
Yi-Feng HouDepartment of Breast Surgery, Fudan University Shanghai Cancer and Key Laboratory of Breast Cancer in Shanghai, Shanghai, China.
Gen-Hong DiDepartment of Breast Surgery, Fudan University Shanghai Cancer and Key Laboratory of Breast Cancer in Shanghai, Shanghai, China.
Guang-Yu LiuDepartment of Breast Surgery, Fudan University Shanghai Cancer and Key Laboratory of Breast Cancer in Shanghai, Shanghai, China.
Ke-Da YuDepartment of Breast Surgery, Fudan University Shanghai Cancer and Key Laboratory of Breast Cancer in Shanghai, Shanghai, China.
Jiong WuDepartment of Breast Surgery, Fudan University Shanghai Cancer and Key Laboratory of Breast Cancer in Shanghai, Shanghai, China.
Xia YanDepartment of Breast Surgery, Fudan University Shanghai Cancer and Key Laboratory of Breast Cancer in Shanghai, Shanghai, China.
Xiao-Hua ZengBreast Center, Chongqing Cancer Hospital, Chongqing University, Chongqing, China.
De-Yuan FuDepartment of Thyroid and Breast Surgery, Northern Jiangsu People's Hospital, Yangzhou, Jiangsu, China.
Chuan-Gui SongDepartment of Breast Surgery, Fujian Medical University Union Hospital, Fuzhou, Fujian Province, China.
Zhi-Gang ZhuangDepartment of Breast Surgery, Shanghai First Maternity and Infant Hospital, Shanghai Tongji University, Shanghai, China.
Ke-Jin WuDepartment of Breast Surgery, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.
Jie WangDepartment of Breast Surgery, The International Peace Maternity and Child Health Hospital of China Welfare Institute, Shanghai Jiao Tong University, Shanghai, China.
Zhong-Hua WangDepartment of Breast Surgery, Fudan University Shanghai Cancer and Key Laboratory of Breast Cancer in Shanghai, Shanghai, China.
Zhi-Ming ShaoDepartment of Breast Surgery, Fudan University Shanghai Cancer and Key Laboratory of Breast Cancer in Shanghai, Shanghai, China zhimingshao@fudan.edu.cn.ORCID 0000-0002-4503-148X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the feasibility of using a multigene signature to tailor individualised adjuvant therapy for patients with operable triple negative breast cancer.

designRandomised, multicentre, open label, phase 3 trial.

setting7 cancer centres in China between 3 January 2016 and 17 July 2023.

participantsFemale patients aged 18-70 years with early triple negative breast cancer after definitive surgery.

interventionsAfter risk stratification using the integrated signature, patients at high risk were randomised (1:1) to receive an intensive adjuvant treatment comprising four cycles of docetaxel, epirubicin, and cyclophosphamide followed by four cycles of gemcitabine and cisplatin (arm A; n=166) or a standard treatment of four cycles of epirubicin and cyclophosphamide followed by four cycles of docetaxel (arm B; n=170). Patients at low risk received the same adjuvant chemotherapy as arm B (arm C; n=168).

main outcome measuresThe primary endpoint was disease-free survival in the intention-to-treat analysis for arm A versus arm B. Secondary endpoints included disease-free survival for arm C versus arm B, recurrence-free survival, overall survival, and safety.

resultsAmong the 504 enrolled patients, 498 received study treatment. At a median follow-up of 45.1 months, the three year disease-free survival rate was 90.9% for patients in arm A and 80.6% for patients in arm B (hazard ratio 0.51, 95% confidence interval (CI) 0.28 to 0.95; P=0.03). The three year recurrence-free survival rate was 92.6% in arm A and 83.2% in arm B (hazard ratio 0.50, 95% CI 0.25 to 0.98; P=0.04). The three year overall survival rate was 98.2% in arm A and 91.3% in arm B (hazard ratio 0.58, 95% CI 0.22 to 1.54; P=0.27). The rates of disease-free survival (three year disease-free survival 90.1%

conclusionsThe multigene signature showed potential for tailoring adjuvant chemotherapy for patients with operable triple negative breast cancer. Intensive regimens incorporating gemcitabine and cisplatin into anthracycline/taxane based therapy significantly improved disease-free survival with manageable toxicity.

trial registrationClinicalTrials.gov NCT02641847.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCyclophosphamideDeoxycytidineDocetaxelEpirubicinGemcitabineTriple Negative Breast NeoplasmsAdolescentAdultAgedChemotherapy, AdjuvantChinaCisplatinDisease-Free SurvivalFemaleHumansCisplatinCyclophosphamideDeoxycytidineDocetaxelEpirubicinGemcitabine

Identifiers

PMID39442958
PMCPMC11497771

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.