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MINT I Multi- Institutional Neo-adjuvant Therapy MammaPrint Project I (MINT)

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
TAC chemotherapy
TC chemotherapy
Dose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapy
TCH chemotherapy
T + trastuzumab followed by CEF + trastuzumab
Dose dense AC followed by T + trastuzumab
Dose dense AC followed by T + trastuzumab + pertuzumab
PTH followed by dose dense AC of FEC
Sponsored by
Agendia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring breast cancer, neo adjuvant therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women with histologically proven invasive breast cancer and no distant metastases and;
  • Lymphnode negative and a clinical tumor classification of T2 (≥3.5cm)-T4 or with 1-3 positive lymph nodes and a clinical tumor classification of T2-T4 DCIS or LCIS are allowed in addition to invasive cancer at T2 or T3 level.
  • Age ≥ 18 years.
  • At least one lesion that can be accurately measured in two dimensions utilizing mammogram, ultrasound, or MRI images to define specific size and validate complete pathologic response.
  • Adequate bone marrow reserves (neutrophil count >1.5 x109 /l and platelet count >100 x109/l), adequate renal function (serum creatinine ≤ 1.5 x upper limit of normal) and hepatic function (ALAT, ASAT ≤ 2.5 x upper limit of normal, alkaline phosphatase ≤ 2.5 x upper limit of normal and total bilirubin ≤ 2.0 x upper limit of normal).
  • Signed informed consent of the patient

Exclusion Criteria:

  • Any patient with confirmed metastatic disease. Patients with inflammatory breast cancer.
  • Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails Quality Assurance or Quality Control criteria.
  • Patients who have had any prior chemotherapy, radiotherapy, or endocrine therapy for the treatment of breast cancer.
  • Any serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease.

Sites / Locations

  • University of South Alabama, Mitchell Cancer Institute
  • Morton Plant Mease Health Care
  • University of Miami
  • University of South Florida Breast Cancer Program
  • Helen Ellis Memorial Hospital
  • Eastchester Center for Cancer Care
  • Ohio State University Comprehensive Cancer Center
  • University of Oklahoma, Health Sciences Center
  • Texas Health, Plano Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

HER2 negative patients

Her2 positive patients

Arm Description

In order to provide some consistency in management and have a treatment policy in place only recommended therapy with several well accepted and presumed equivalent chemotherapy regimens will be used. The proposed neo-adjuvant chemotherapy regimens for HER2 negative patients include: TAC chemotherapy TC chemotherapy Dose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapy

The proposed neo-adjuvant chemotherapy regimens for HER2 negative patients is TCH chemotherapy.

Outcomes

Primary Outcome Measures

Determine the predictive power of chemosensitivity of MammaPrint as measured by pCR.
Determine the predictive power of chemosensitivity of the combination of MammaPrint and BluePrint as measured by pCR.

Secondary Outcome Measures

Compare TargetPrint single gene read out of ER, PR and HER2 with local and centralized IHC and/or CISH/FISH assessment of ER, PR and HER2.
Identify possible correlations between the TheraPrint Research Gene Panel outcomes and chemoresponsiveness.
Identify and/or validate predictive gene expression profiles of clinical response/resistance to chemotherapy.
Compare the three BluePrint molecular subtype categories with IHC-based subtype classification.

Full Information

First Posted
December 22, 2011
Last Updated
June 26, 2018
Sponsor
Agendia
Collaborators
University of South Florida, University of Miami, Morton Plant Mease Health Care, AdventHealth, Plano Cancer Center, Ohio State University Comprehensive Cancer Center, University of Oklahoma, University of South Alabama
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1. Study Identification

Unique Protocol Identification Number
NCT01501487
Brief Title
MINT I Multi- Institutional Neo-adjuvant Therapy MammaPrint Project I
Acronym
MINT
Official Title
MINT I Multi- Institutional Neo-adjuvant Therapy MammaPrint Project I
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Agendia
Collaborators
University of South Florida, University of Miami, Morton Plant Mease Health Care, AdventHealth, Plano Cancer Center, Ohio State University Comprehensive Cancer Center, University of Oklahoma, University of South Alabama

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Genomics assays that measure specific gene expression patterns in a patient's primary tumor have become important prognostic tools for breast cancer patients. This study is designed to test the ability of MammaPrint® in combination with TargetPrint®, BluePrint®, and TheraPrint®, as well as traditional pathologic and clinical prognostic factors, to predict responsiveness to neo-adjuvant chemotherapy in patients with locally advanced breast cancer (LABC).
Detailed Description
Patients with suspected primary breast cancer on mammography and clinical examination will be assessed for eligibility by having a needle core biopsy to confirm invasive carcinoma. A fresh unfixed tumor specimen, incisional or core biopsy will be sent to Agendia to determine the MammaPrint risk profile, the BluePrint molecular subtyping profile, the TargetPrint ER, PR and HER2 single gene readout, the 56-geneTheraPrint Research Gene Panel and the additional genes as measured on the whole genome (44k) array. Surgical Protocol: Determination of nodal status: For clinically node-negative patients: Axillary ultra sound, followed by Sentinel Lymph Node (SLN) biopsy For clinically node-positive patients: ultra sound-guided Fine Needle Aspirate (FNA), followed by core biopsy Neo-adjuvant chemotherapy Definitive surgery: For node-positive patients: lumpectomy, repeat SLN biopsy, Axillary Lymph Node Dissection (ALND) For node-negative patients: lumpectomy, repeat SLN biopsy (optional), no ALND Response will be measured by pathological Complete Response (pCR) and by centrally assessed Residual Cancer Burden (RCB).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, neo adjuvant therapy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
226 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HER2 negative patients
Arm Type
Active Comparator
Arm Description
In order to provide some consistency in management and have a treatment policy in place only recommended therapy with several well accepted and presumed equivalent chemotherapy regimens will be used. The proposed neo-adjuvant chemotherapy regimens for HER2 negative patients include: TAC chemotherapy TC chemotherapy Dose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapy
Arm Title
Her2 positive patients
Arm Type
Active Comparator
Arm Description
The proposed neo-adjuvant chemotherapy regimens for HER2 negative patients is TCH chemotherapy.
Intervention Type
Drug
Intervention Name(s)
TAC chemotherapy
Intervention Description
Docetaxel 75 mg/m2 IV day 1, Doxorubicin 50 mg/m2 IV day 1, Cyclophosphamide 500 mg/m2 IV day 1; Cycled every 21 days for 6 cycles
Intervention Type
Drug
Intervention Name(s)
TC chemotherapy
Intervention Description
Docetaxel 75 mg/m2 IV day 1, Cyclophosphamide 600 mg/m2 IV day 1; Cycled every 21 days for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Dose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapy
Intervention Description
Doxorubicin 60 mg/m2 IV day 1, Cyclophosphamide 600 mg/m2 IV day 1, Cycled every 14 days for 4 cycles, OR 5-Fluorouracil 500 mg/m2 IV day 1, Epirubicin 100 mg/m2 IV day 1, Cyclophosphamide 500 mg/m2 IV day 1; Cycled every 21 days for 3 cycles Followed by Paclitaxel 80 mg/m2 by 1 h IV infusion weekly for 12 weeks, OR Docetaxel 100mg/m2 IV day 1 cycled every 21 days for 3 or 4 cycles
Intervention Type
Drug
Intervention Name(s)
TCH chemotherapy
Intervention Description
Docetaxel 75 mg/m2 IV day 1, followed by Carboplatin AUC 6 IV day 1; Cycled every 21 days for 6 cycles Trastuzumab initial dose of 4 mg/kg over 90 minute IV infusion, then 2 mg/kg over 30 minute IV infusion weekly for 52 weeks, OR initial dose of 8 mg/kg over 90 minutes IV infusion, then 6 mg/kg over 30-90 minutes IV infusion every three weeks for 52 weeks.
Intervention Type
Drug
Intervention Name(s)
T + trastuzumab followed by CEF + trastuzumab
Intervention Description
Trastuzumab 4 mg/kg IV for one dose beginning just prior to first dose of paclitaxel. Followed by trastuzumab 2 mk/kg IV weekly for 23 weeks Paclitaxel 80 mg/m2 by 1 h IV infusion weekly for 12 wks Followed by 5-Fluorouracil 500 mg/m2 IV on days 1 and 4 Epirubicin 75 mg/m2 IV on day 1 Cyclophosphamide 500 mg/m2 IV on day 1 cycled every 21 days for 4 cycles Trastuzumab 6mg/kg IV every 21 days for 9 cycles to complete 1yr
Intervention Type
Drug
Intervention Name(s)
Dose dense AC followed by T + trastuzumab
Intervention Description
Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 (cycled every 14 days for 4 cycles) Followed by paclitaxel 80 mg/m2 by 1 h IV infusion weekly for 12 wks All cycles are with filgrastim support with trastuzumab 2 mg/kg (4 mg/kg loading dose). Following chemotherapy , trastuzumab to continue every 3 weeks at 6 mg/kg for the duration of 1 week.
Intervention Type
Drug
Intervention Name(s)
Dose dense AC followed by T + trastuzumab + pertuzumab
Intervention Description
Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 Cycled every 14 days for 4 cycles Followed by docetaxel 75-100 mg/m2 by 1 h IV infusion weekly for 12 wks All cycles are with filgrastim support with trastuzumab 6 mg/kg (8 mg/kg loading dose with C1) Pertuzumab 420 mg (840 mg loading dose with C1). Following chemotherapy, trastuzumab to continue every 3 weeks at 6 mg/kg for the duration of 1 week.
Intervention Type
Drug
Intervention Name(s)
PTH followed by dose dense AC of FEC
Intervention Description
Docetaxel 75-100 mg/m2 by 1 h IV infusion Cycled every 21 days for 4 cycles With Trastuzumab 6 mg/kg IV (8 mg/kg IV loading dose) q3W And Pertuzumab 420 mg IV (840 mg IV loading dose) q 3w +/- pegfilgrastim 6 mg sq on day 2-3, Followed by 4 cycles of AC or FEC: AC Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 Cycled every 14 days for 4 cycles with pegfilgrastim 6 mg sq on day 2 FEC 5-Fluorouracil 500 mg/m2 IV on days 1 and 4 Epirubicin 75 mg/m2 IV on day 1 Cyclophosphamide 500 mg/m2 IV on day 1 cycled every 21 days for 4 cycles In all of the above mentioned regimens docetaxel might be substituted with paclitaxel as paclitaxel is better tolerated but is expected to have the same efficacy as docetaxel.
Primary Outcome Measure Information:
Title
Determine the predictive power of chemosensitivity of MammaPrint as measured by pCR.
Time Frame
6-12 months
Title
Determine the predictive power of chemosensitivity of the combination of MammaPrint and BluePrint as measured by pCR.
Time Frame
6-12 months
Secondary Outcome Measure Information:
Title
Compare TargetPrint single gene read out of ER, PR and HER2 with local and centralized IHC and/or CISH/FISH assessment of ER, PR and HER2.
Time Frame
Baseline. First study visit.
Title
Identify possible correlations between the TheraPrint Research Gene Panel outcomes and chemoresponsiveness.
Time Frame
6-9 months
Title
Identify and/or validate predictive gene expression profiles of clinical response/resistance to chemotherapy.
Time Frame
6-12 months
Title
Compare the three BluePrint molecular subtype categories with IHC-based subtype classification.
Time Frame
Baseline. First study visit.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women with histologically proven invasive breast cancer and no distant metastases and; Lymphnode negative and a clinical tumor classification of T2 (≥3.5cm)-T4 or with 1-3 positive lymph nodes and a clinical tumor classification of T2-T4 DCIS or LCIS are allowed in addition to invasive cancer at T2 or T3 level. Age ≥ 18 years. At least one lesion that can be accurately measured in two dimensions utilizing mammogram, ultrasound, or MRI images to define specific size and validate complete pathologic response. Adequate bone marrow reserves (neutrophil count >1.5 x109 /l and platelet count >100 x109/l), adequate renal function (serum creatinine ≤ 1.5 x upper limit of normal) and hepatic function (ALAT, ASAT ≤ 2.5 x upper limit of normal, alkaline phosphatase ≤ 2.5 x upper limit of normal and total bilirubin ≤ 2.0 x upper limit of normal). Signed informed consent of the patient Exclusion Criteria: Any patient with confirmed metastatic disease. Patients with inflammatory breast cancer. Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails Quality Assurance or Quality Control criteria. Patients who have had any prior chemotherapy, radiotherapy, or endocrine therapy for the treatment of breast cancer. Any serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles E Cox, MD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Alabama, Mitchell Cancer Institute
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36688
Country
United States
Facility Name
Morton Plant Mease Health Care
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33124
Country
United States
Facility Name
University of South Florida Breast Cancer Program
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Helen Ellis Memorial Hospital
City
Tarpon Springs
State/Province
Florida
ZIP/Postal Code
34689
Country
United States
Facility Name
Eastchester Center for Cancer Care
City
Bronx
State/Province
New York
ZIP/Postal Code
10469
Country
United States
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
University of Oklahoma, Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Texas Health, Plano Cancer Institute
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States

12. IPD Sharing Statement

Learn more about this trial

MINT I Multi- Institutional Neo-adjuvant Therapy MammaPrint Project I

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