Biomarkers Investigation of Neoadjuvant Chemotherapy for Breast Cancer

NCT03242551 | Unknown Phase 2 DMC

• 1 other identifier: Shenzhen BC-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

The BINC-B trial is a diagnostic and interventional study in which various function imaging methods as Magnetic Resonance Imaging (PWI, DWI and DCE-MRI) and will be compared with common imaging methods (mammography and/or ultrasound) to investigate if an early response to a combined neoadjuvant chemotherapy in operable or potentially operable breast cancer. For breast cancer patients with positive HER-2, additional Herceptin could improve the response further. In this study the efficacy of combined neoadjuvant therapy with or without Herceptin should be evaluated and the role in predicting the tumor response with different imaging should be estimated.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• pathological complete response (pCR)

  Rate of pathological complete response (pCR) following neoadjuvant therapy and to determine efficacy of neoadjuvant therapy in primary breast cancer using pCR (According to National Surgical Adjuvant Breast and Bowel Project guideline)

  from the first day of the the first cycle (each cycle is 14 days) of neoadjuvant chemotherapy to the date that breast and axillary sugery will be performed

Secondary Outcomes (3)

• Response rate

  from the first day of the the first cycle (each cycle is 14 days) of neoadjuvant chemotherapy to the date that breast and axillary sugery will be performed

• Disease free survival

  from the first day of the the first cycle of neoadjuvant chemotherapy (each cycle is 14 days) to the date of first documented progression or date of death from breast cancer, whichever came first, assessed up to 60 months

• Overall survival

  from the first day of the the first cycle (each cycle is 14 days) of neoadjuvant chemotherapy to the date of death from any cause, whichever came first, assessed up to 60 months

Study Arms (1)

Neoadjuvant chemotherapy

EXPERIMENTAL

Epirubicin 100mg/m2 and cyclophosphamine 600mg/m2 for four cycles followed by paclitaxol 175mg/m2 for four cycles with (for patients with positive HER-2) or without Trastuzumab (loading dose of 6 mg/kg followed by 4 mg/kg every 2 weeks for four cycles), each cycle is 14 days.

Drug: Chemotherapy

Interventions

Chemotherapy DRUG

"AC" followed by "T" Chemotherapy with or without trastuzumab, i.e. Epirubicin 100mg/m2 and cyclophosphamine 600mg/m2 for four cycles followed by paclitaxol 175mg/m2 for four cycles with (for patients with positive HER-2) or without Trastuzumab (loading dose of 6 mg/kg followed by 4 mg/kg every 2 weeks for four cycles), each cycle is 14 days.

Neoadjuvant chemotherapy

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years and ≤70 years
• Female
• Operable or potentially operable primary breast cancer (≥ cT2, N0 or N+, M0);
• Confirmed by core biopsy
• Histological confirmed unilateral, solitaire breast cancer
• Baseline LVEF ≥55% (measured by echocardiography) according to institution specific norm
• Informed consent for clinical trial including analysis of predictive imaging tests and biomarkers
• Clinically or by imaging (mammogram, MRI or US) assessed breast cancer ≥2 cm with bi-dimensional measurable lesion independent of nodal status
• Negative pregnancy test (urine or serum) within 7 days prior to registration if patient is premenopausal with intact reproductive organs and if patient is less than one year after menopause
• ECOG Performance status 0-2
• Adequate organ function for cytotoxic chemotherapy
• Adequate renal function including Serum creatinine ≤ ULN, Measured or calculated creatinine clearance \> 60 ml per min
• Absolute neutrophil count ≤ 1500/µL, platelet count ≥ 100,000/µL
• Bilirubin ≤ ULN; ALT or AST ≤ 1.5 x ULN, and alkaline phosphatase ≤2.5 x ULN
• Patients must be available and compliant for treatment and follow-up

You may not qualify if:

• Evidence of distant metastases by clinical or imaging diagnosis
• Multifocal primary tumor, defined as histologically confirmed tumor-manifestations within different quadrants; distance ≥ 4 cm
• Pre-existing motor or sensory neuropathy of a severity ≥ grade 2 NCI criteria
• Previous breast cancer
• Prior malignancy with a disease-free survival of \< 5 year
• Prior malignancy which has not been curatively treated
• Inflammatory breast cancer
• Prior systemic therapy for cancer
• Patients with immunosuppressive therapy
• Pregnant or lactating women
• Women of childbearing potential not using highly effective birth control
• Patients with known hypersensitivity reactions to the compounds or incorporated substances of trastuzumab or its constituents (for HER2+ tumors)
• Invasive malignancy which could affect compliance with the protocol or interpretation of results
• Other serious illness or medical condition including: Known or suspected congestive heart failure (\>NYHA I) and/or coronary heart disease, Angina pectoris requiring antianginal medication; Previous history of myocardial infarction, Evidence of transmural infarction on ECG, Un- or poorly controlled arterial hypertension (i.e. BP \>150/100 mmHg under treatment with two antihypertensive drugs), Rhythm abnormalities requiring permanent treatment; Clinically significant valvular heart disease, Patients with dyspnea at rest due to malignant or other disease or who require supportive oxygen therapy, Active serious uncontrolled infections, Poorly controlled diabetes, History of hypertensive crisis or hypertensive encephalopathy; History of TIA or CVA
• Neutrophil count of \< 1500, platelet count of \< 100,000/µL, Haemoglobin \< 10 g/dL

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Sites (2)

Department of Oncology

Shenzhen, Guangdong, 518020, China

NOT YET RECRUITING

Shenzhen People Hospital

Shenzhen, Guangdong, 518020, China

RECRUITING

Related Publications (5)

• Marinovich ML, Sardanelli F, Ciatto S, Mamounas E, Brennan M, Macaskill P, Irwig L, von Minckwitz G, Houssami N. Early prediction of pathologic response to neoadjuvant therapy in breast cancer: systematic review of the accuracy of MRI. Breast. 2012 Oct;21(5):669-77. doi: 10.1016/j.breast.2012.07.006. Epub 2012 Aug 3.

  PMID: 22863284 BACKGROUND

• Prevos R, Smidt ML, Tjan-Heijnen VC, van Goethem M, Beets-Tan RG, Wildberger JE, Lobbes MB. Pre-treatment differences and early response monitoring of neoadjuvant chemotherapy in breast cancer patients using magnetic resonance imaging: a systematic review. Eur Radiol. 2012 Dec;22(12):2607-16. doi: 10.1007/s00330-012-2653-5. Epub 2012 Sep 16.

  PMID: 22983282 BACKGROUND

• Braman NM, Etesami M, Prasanna P, Dubchuk C, Gilmore H, Tiwari P, Plecha D, Madabhushi A. Erratum to: Intratumoral and peritumoral radiomics for the pretreatment prediction of pathological complete response to neoadjuvant chemotherapy based on breast DCE-MRI. Breast Cancer Res. 2017 Jul 10;19(1):80. doi: 10.1186/s13058-017-0862-1. No abstract available.

  PMID: 28693537 BACKGROUND

• Murtaza M, Dawson SJ, Tsui DW, Gale D, Forshew T, Piskorz AM, Parkinson C, Chin SF, Kingsbury Z, Wong AS, Marass F, Humphray S, Hadfield J, Bentley D, Chin TM, Brenton JD, Caldas C, Rosenfeld N. Non-invasive analysis of acquired resistance to cancer therapy by sequencing of plasma DNA. Nature. 2013 May 2;497(7447):108-12. doi: 10.1038/nature12065. Epub 2013 Apr 7.

  PMID: 23563269 BACKGROUND

• Morganella S, Alexandrov LB, Glodzik D, Zou X, Davies H, Staaf J, Sieuwerts AM, Brinkman AB, Martin S, Ramakrishna M, Butler A, Kim HY, Borg A, Sotiriou C, Futreal PA, Campbell PJ, Span PN, Van Laere S, Lakhani SR, Eyfjord JE, Thompson AM, Stunnenberg HG, van de Vijver MJ, Martens JW, Borresen-Dale AL, Richardson AL, Kong G, Thomas G, Sale J, Rada C, Stratton MR, Birney E, Nik-Zainal S. The topography of mutational processes in breast cancer genomes. Nat Commun. 2016 May 2;7:11383. doi: 10.1038/ncomms11383.

  PMID: 27136393 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Wenyong Tan, Dr.

  Shenzhen People Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenyong Tan, Dr

CONTACT

008618924672707; tanwyym@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: epirubicin, paclitaxol, cyclophosphamide, trastuzumab

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 8, 2017
• Study Start: November 8, 2017
• Primary Completion: August 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 14, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After the data is formally published
• Access Criteria: open acess

Locations

CN (2)