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The investigators hypothesize that paclitaxel combined with cisplatin in a weekly-based regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast cancer.
In patients with some sub-type advanced breast cancer, neo-adjuvant chemotherapy combined with endocrine therapy may improve the pathological remission rate.
Premenopausal patients with triple negative breast caner and hormonal receptor positve breast cancer patients will be randominzed to have neoadjuvant chemotherapy combined with endocrine therapy or not.
In this trial, patients with ER and or PR positive breast cancer will be separately randomized to have chemotherapy or chemotherapy combined with endocrine therapy according to their menstrual status. Letrozole for the postmenopausal women and ovarian function suppression for the premenopausal women. Patients with triple negative breast cancer will be randomized to have neoadjuvant chemotherapy combined with ovarian function suppression if she is premenopausal. Postermenopausal patients with triple negative breast caner will only have neoadjuvant chemotherapy.
Patients with Her2 overexpression can obtain anti-Her2 target therapy. This study has been amended to a 1:2 ratio to control and neoadjuvant chemotherapy combination of endocrine therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy only | Active Comparator | Paclitaxel injection 80mg/m2,given on days1,8,15 and 22 of a 28-day cycle;Cisplatin 25mg/m2, given on days 1,8,and 15 of a 28-day cycle; for 4 cycles |
|
| GnRHa | Experimental | Paclitaxel 80mg/m2,given on days1,8,15 and 22 of a 28-day cycle; Cisplatin 25mg/m2, given on days 1,8,and 15 of a 28-day cycle; for 4 cycles Gonadotropin-releasing hormone agonist (GnRHa)11.25 mg every 3 months or 3.6mg every month subcutaneously |
|
| letrozole | Experimental | Paclitaxel 80mg/m2,given on days1,8,15 and 22 of a 28-day cycle; Cisplatin 25mg/m2, given on days 1,8,and 15 of a 28-day cycle; for 4 cycles Letrozole 2.5mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| pathological complete remission rate | Pathological complete remission is defined as no invasive cancer in breast and axillary nodes. | after 4 months preoperative treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Drug Related Treatment Adverse Events | Adverse events that occurred on or after initial treatment that were absent before treatment or worsened during the treatment period relative to the pretreatment state. | 4 months during neoadjuvant therapy |
| Clinical and imaging response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinsong Lu | RenJi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Thyroid and Breast Gland Surgery,Shenzhen Longgang Central Hospital | Shenzhen | Guangdong | China | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38129778 | Derived | Wan C, Zhou L, Jin Y, Li F, Wang L, Yin W, Wang Y, Li H, Jiang L, Lu J. Strain ultrasonic elastography imaging features of locally advanced breast cancer: association with response to neoadjuvant chemotherapy and recurrence-free survival. BMC Med Imaging. 2023 Dec 21;23(1):216. doi: 10.1186/s12880-023-01168-2. | |
| 33154826 | Derived |
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| Cisplatin |
| Drug |
|
| Gonadotropin-releasing hormone agonist | Drug | Goserelin 3.6 mg q28d or Leuprolide 11.25 mg q3m |
|
| Letrozole | Drug |
|
To determine the response rates of the breast tumor and axillary nodes based on physical examination and imaging tests. (sonography, mammography, or MRI) after treatment |
| 4 months during treatment |
| disease free survival (DFS) | DFS is defined as the time in months from randomization until first occurrence of locoregional recurrence, distant metastasis, contralateral breast cancer, second primary tumor, or death from any cause. | 5 years |
| regional recurrence free survival (RRFS) | RRFS is defined as the time period between registration and first event | 5 years |
| local recurrence free survival (LRFS) | LRFS is defined as the time period between registration and first event | 5 years |
| overall survival (OS) | OS is defined as the time period between registration and first event | 5 years |
| distant-disease- free survival (DDFS) | DDFS is defined as the time period between registration and first event | 5 years |
| rate of tumor remission (RTR) | RTR is defined as the proportion of tumor remission per unit time | after 2 cycles and 4 cycles during neoadjuvant therapy |
| serum markers | Changes in the angiogenic serum markers(mirRNA, lncRNA, cirRNA), measured at diagnosis and surgery | Pre-treatment and/or surgical |
| molecular markers | Pre-treatment and surgical expression of molecular markers (LHRHa receptor, EGFR,PD-L1) | Pre-treatment and/or surgical |
| HanDan Central Hospital |
| Handan |
| Hebei |
| 056001 |
| China |
| The First Affiliated Hospital of University of South China | Hengyang | Hunan | 421001 | China |
| Department of Thyroid and Breast Surgery, The Affiliated Hospital of Inner Mongolia Medical Collage | Hohhot | Inner Mongolia | China |
| The second people's hospital of Kunshan city | Kunshan | Jiangsu | 215300 | China |
| Department of Medical Oncology, General Hospital of Ningxia Medical University | Yinchuan | Ningxia | China |
| Zhongshan Hospital | Shanghai | Shanghai Municipality | 200032 | China |
| Shanghai Jiaotong University School of Medicine, Renji Hospital | Shanghai | Shanghai Municipality | 200127 | China |
| Yueyang hospital of integrated traditional Chinese and Western medine | Shanghai | Shanghai Municipality | 200437 | China |
| Armed Police Corps Hospital of Shanghai | Shanghai | Shanghai Municipality | 201103 | China |
| Department of Breast Surgery, Obstetrics and Gynecology Hospital of Fudan University | Shanghai | Shanghai Municipality | China |
| Zhoushan hospital | Zhoushan | Zhejiang | 316021 | China |
| Sun L, Yin W, Wu Z, Wang Y, Lu J. The Predictive Value of Pre-therapeutic Serum Gamma-glutamyl transferase in Efficacy and Adverse Reactions to Neoadjuvant Chemotherapy among Breast Cancer Patients. J Breast Cancer. 2020 Oct;23(5):509-520. doi: 10.4048/jbc.2020.23.e59. |
| 31488093 | Derived | Bayarmaa B, Wu Z, Peng J, Wang Y, Xu S, Yan T, Yin W, Lu J, Zhou L. Association of LncRNA MEG3 polymorphisms with efficacy of neoadjuvant chemotherapy in breast cancer. BMC Cancer. 2019 Sep 5;19(1):877. doi: 10.1186/s12885-019-6077-3. |
| 30976202 | Derived | Wu Z, Zhang L, Xu S, Lin Y, Yin W, Lu J, Sha R, Sheng X, Zhou L, Lu J. Predictive and prognostic value of ZEB1 protein expression in breast cancer patients with neoadjuvant chemotherapy. Cancer Cell Int. 2019 Mar 29;19:78. doi: 10.1186/s12935-019-0793-2. eCollection 2019. |
| ID | Term |
|---|---|
| D018270 | Carcinoma, Ductal, Breast |
| D058922 | Inflammatory Breast Neoplasms |
| ID | Term |
|---|---|
| D044584 | Carcinoma, Ductal |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D002945 | Cisplatin |
| D007987 | Gonadotropin-Releasing Hormone |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D009570 | Nitriles |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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