Weekly Paclitaxel and Cisplatin to Treat Hormone Receptor Positive and Triple Negative Breast Cancer Patients

NCT02221999 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: RenJiH-BC-002
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 12

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.

Conditions

Tubular Breast Cancer; Mucinous Breast Cancer; Invasive Ductal Breast Cancer; Inflammatory Breast Cancer

Outcome Measures

Primary Outcomes (1)

• pathological complete remission rate

  Pathological complete remission is defined as no invasive cancer in breast and axillary nodes.

  after 4 months preoperative treatment

Secondary Outcomes (10)

• Number of Participants With Drug Related Treatment Adverse Events

  4 months during neoadjuvant therapy

• Clinical and imaging response

  4 months during treatment

• disease free survival (DFS)

  5 years

• regional recurrence free survival (RRFS)

  5 years

• local recurrence free survival (LRFS)

  5 years

Study Arms (3)

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

Drug: Paclitaxel; Drug: Cisplatin

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

Drug: Paclitaxel; Drug: Cisplatin; Drug: Gonadotropin-releasing hormone agonist

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

Drug: Paclitaxel; Drug: Cisplatin; Drug: Letrozole

Interventions

Paclitaxel DRUG

Also known as: Taxol

Chemotherapy only; GnRHa; letrozole

Cisplatin DRUG

Chemotherapy only; GnRHa; letrozole

Gonadotropin-releasing hormone agonist DRUG

Goserelin 3.6 mg q28d or Leuprolide 11.25 mg q3m

GnRHa

Letrozole DRUG

letrozole

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged ≥18years and ≤70 years;
• 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;
• 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.
• No prior systemic or loco-regional treatment of breast cancer;
• 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;
• No obvious main organs dysfunction.

You may not qualify if:

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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (12)

Department of Thyroid and Breast Gland Surgery,Shenzhen Longgang Central Hospital

Shenzhen, Guangdong, China

Location

HanDan Central Hospital

Handan, Hebei, 056001, China

Location

The First Affiliated Hospital of University of South China

Hengyang, Hunan, 421001, China

Location

Department of Thyroid and Breast Surgery, The Affiliated Hospital of Inner Mongolia Medical Collage

Hohhot, Inner Mongolia, China

Location

The second people's hospital of Kunshan city

Kunshan, Jiangsu, 215300, China

Location

Department of Medical Oncology, General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Location

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Shanghai Jiaotong University School of Medicine, Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

Yueyang hospital of integrated traditional Chinese and Western medine

Shanghai, Shanghai Municipality, 200437, China

Location

Armed Police Corps Hospital of Shanghai

Shanghai, Shanghai Municipality, 201103, China

Location

Department of Breast Surgery, Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Location

Zhoushan hospital

Zhoushan, Zhejiang, 316021, China

Location

Related Publications (4)

• 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.

  PMID: 38129778 DERIVED

• 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.

  PMID: 33154826 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.

  PMID: 31488093 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.

  PMID: 30976202 DERIVED

MeSH Terms

Conditions

Carcinoma, Ductal, Breast; Inflammatory Breast Neoplasms

Interventions

Paclitaxel; Cisplatin; Gonadotropin-Releasing Hormone; Letrozole

Condition Hierarchy (Ancestors)

Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jinsong Lu

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: August 21, 2014
• Study Start: September 1, 2013
• Primary Completion: January 1, 2019
• Study Completion (Estimated): January 1, 2029
• Last Updated: August 29, 2023

Record last verified: 2023-08

Locations

CN (12)