Biomarkers Investigation of Neoadjuvant Chemotherapy for Breast Cancer (BINC-B)

November 10, 2017 updated by: Wenyong Tan, Shenzhen People's Hospital

The Role of Multimodal Imaging and Circulating Biomarkers in Predicting the Response of Neoadjuvant Chemotherapy for Breast Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Firstly, the investigators aim to show that the results of functional imaging including dynamic enhanced, diffuse weighted, and perfusion MR imaging biomarkers as well the ultrasonic outcome could be used to predict the response to the neoadjuvant chemotherapy for operable and potentially operable breast cancer (luminal B, HER-2 positive and triple negative).

Secondly, the investigators will study the role of peripheral blood biomarker including circulating tumor DNA (ctDNA), circulating endothelial cells (CECs) and subsets, myeloid-derived suppressor cells (MDSCs), and lymph cell subsets and their combinations could predict the response of the tumor measured with imaging.

Thirdly, the investigators will establish a mode with these multiple imaging and serum biomarker panel as well as their changes during the treatment course establish to predict the response to neoadjuvant chemotherapy.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518020
        • Not yet recruiting
        • Department of Oncology
        • Contact:
        • Contact:
      • Shenzhen, Guangdong, China, 518020

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
  • Inadequate bone marrow, hepatic and renal functions as evidenced by the following: Serum total bilirubin > ULN, ALT or AST > 1.5 x ULN, Alkaline phosphatase > 2.5 x ULN, serum creatinine > ULN
  • Concurrent treatment with any other anti-cancer therapy
  • No informed consent for analysis of predictive imaging tests and biomarkers
  • Contraindications against MRI: Cardiac pacemakers, other forms of medical or biostimulation implants, ferromagnetic foreign bodies or metallic implants (e.g. surgical protheses, aneurysm clips), implanted insulin pumps, valvular implants, allergy to contrast agent, renal insufficiency, claustrophobia
  • Active peptic ulcer, incomplete wound healing or unhealed bone fracture
  • Disease significantly affecting gastrointestinal function, e.g. malabsorption syndrome, resection of the stomach or small bowel, ulcerative colitis, abdominal fistula, intra-abdominal abscess within 6 months of enrolment or gastrointestinal perforation
  • Concurrent treatment with other experimental drugs; participation in another clinical trial with any investigational drug within 30 days prior to study entry
  • Chronic daily treatment with corticosteroids (dose of > 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neoadjuvant chemotherapy
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
"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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pathological complete response (pCR)
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: 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
the summary of clinical complete response and partial response (RESICIST 1.1 criteria)
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
Time Frame: 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
from the beginning of neoadjuvant chemotherapy to the confirmed time of recurrence or metastatic disease, or death due to any other cause.
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
Time Frame: 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
from the beginning of neoadjuvant chemotherapy to the death with any causes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen People's Hospital

Investigators

  • Principal Investigator: Wenyong Tan, Dr., Shenzhen People Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2017

Primary Completion (Anticipated)

August 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

July 28, 2017

First Submitted That Met QC Criteria

August 6, 2017

First Posted (Actual)

August 8, 2017

Study Record Updates

Last Update Posted (Actual)

November 14, 2017

Last Update Submitted That Met QC Criteria

November 10, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shenzhen BC-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all the individual data will be open to the other researchers

IPD Sharing Time Frame

After the data is formally published

IPD Sharing Access Criteria

open acess

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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