Clinical trial NCT02221999: Weekly Paclitaxel and Cisplatin to Treat Hormone Receptor Positive and Triple Negative Breast Cancer Patients
Official title: A Prospective, Randomized, Open-label Comparison of Preoperative Weekly Paclitaxel and Cisplatin With or Without Endocrine Therapy in Patients With Operable Hormone Receptor Positive and Triple Negative Locally Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Tubular Breast Cancer
Mucinous Breast Cancer
Invasive Ductal Breast Cancer
Inflammatory Breast Cancer
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2014-08-21
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Women aged ≥18years and ≤70 years;
2. At least on measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST). Histologically confirmed invasive breast cancer, tumor size ≥2 cm, T2-4 N0-3M0;
3. ER/PR/HER-2 and Ki-67 status detected on core biopsy. ER and/or PR positive was defined as \>1% stained cells.HER2-positive is defined as immuno-histochemistry (IHC) 3+ or the ratio of HER2 gene signals to chromosome 17 signals \>2.0 or HER2 gene copy \>6.0.
4. No prior systemic or loco-regional treatment of breast cancer;
5. Adequate bone marrow function:WBC≥4.0×109/L, Absolute neutrophil count（ANC）≥1.5×109/L, Platelets（PLT）≥100×109/L, Hemoglobin（Hb）≥90g/L;aspartate aminotransferase(AST),Alanine aminotransferase (ALT)≤1.5 upper normal limit (UNL), creatinine≤1.5 UNL, bilirubin≤1.5UNL;
6. No obvious main organs dysfunction.

Exclusion Criteria:

1. Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug;
2. Patient is pregnant or breast feeding;
3. Inflammatory breast cancer and metastatic breast cancer;
4. Any evidence of sense or motor nerve disorders;
5. Patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection;
6. Any concurrent malignancy other than breast cancer;
7. Know severe hypersensitivity to any drugs in this study.

Primary outcomes:
measure: pathological complete remission rate
timeFrame: after 4 months preoperative treatment
Secondary outcomes:
measure: Number of Participants With Drug Related Treatment Adverse Events
timeFrame: 4 months during neoadjuvant therapy
measure: Clinical and imaging response
timeFrame: 4 months during treatment
measure: disease free survival (DFS)
timeFrame: 5 years
measure: regional recurrence free survival (RRFS)
timeFrame: 5 years
measure: local recurrence free survival (LRFS)
timeFrame: 5 years
measure: overall survival (OS)
timeFrame: 5 years
measure: distant-disease- free survival (DDFS)
timeFrame: 5 years
measure: rate of tumor remission （RTR）
timeFrame: after 2 cycles and 4 cycles during neoadjuvant therapy
measure: serum markers
timeFrame: Pre-treatment and/or surgical
measure: molecular markers
timeFrame: Pre-treatment and/or surgical
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Department of Thyroid and Breast Gland Surgery,Shenzhen Longgang Central Hospital
state: Guangdong
city: Handan
country: China
facility: HanDan Central Hospital
state: Hebei
city: Hengyang
country: China
facility: The First Affiliated Hospital of University of South China
state: Hunan
city: Hohhot
country: China
facility: Department of Thyroid and Breast Surgery, The Affiliated Hospital of Inner Mongolia Medical Collage
state: Inner Mongolia
city: Kunshan
country: China
facility: The second people's hospital of Kunshan city
state: Jiangsu
city: Yinchuan
country: China
facility: Department of Medical Oncology, General Hospital of Ningxia Medical University
state: Ningxia
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Jiaotong University School of Medicine, Renji Hospital
state: Shanghai
city: Shanghai
country: China
facility: Yueyang hospital of integrated traditional Chinese and Western medine
state: Shanghai
city: Shanghai
country: China
facility: Armed Police Corps Hospital of Shanghai
state: Shanghai
city: Shanghai
country: China
facility: Department of Breast Surgery, Obstetrics and Gynecology Hospital of Fudan University
state: Shanghai
city: Zhoushan
country: China
facility: Zhoushan hospital
state: Zhejiang
Study officials:
affiliation: RenJi Hospital
name: Jinsong Lu
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.