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

Browse trials for

• Breast Neoplasms 12,544

Keywords

• breast cancer
• neo adjuvant therapy

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 226 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Lead sponsor

Agendia is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Study arms

• Active comparator
  HER2 negative patients

  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: 1. TAC chemotherapy 2. TC chemotherapy 3. Dose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapy

  Drug: TAC chemotherapy · Drug: TC chemotherapy · Drug: Dose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapy

• Active comparator
  Her2 positive patients

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

  Drug: TCH chemotherapy · Drug: T + trastuzumab followed by CEF + trastuzumab · Drug: Dose dense AC followed by T + trastuzumab · Drug: Dose dense AC followed by T + trastuzumab + pertuzumab · Drug: PTH followed by dose dense AC of FEC

Interventions

• DrugTAC chemotherapy

  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

• DrugTC chemotherapy

  Docetaxel 75 mg/m2 IV day 1, Cyclophosphamide 600 mg/m2 IV day 1; Cycled every 21 days for 6 cycles

• DrugDose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapy

  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

• DrugTCH chemotherapy

  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.

• DrugT + trastuzumab followed by CEF + trastuzumab

  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

• DrugDose dense AC followed by T + trastuzumab

  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.

• DrugDose dense AC followed by T + trastuzumab + pertuzumab

  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.

• DrugPTH followed by dose dense AC of FEC

  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 outcomes

1. Determine the predictive power of chemosensitivity of MammaPrint as measured by pCR.

   Time frame: 6-12 months

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

   Time frame: 6-12 months

Secondary outcomes

1. 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.

2. Identify possible correlations between the TheraPrint Research Gene Panel outcomes and chemoresponsiveness.

   Time frame: 6-9 months

3. Identify and/or validate predictive gene expression profiles of clinical response/resistance to chemotherapy.

   Time frame: 6-12 months

4. Compare the three BluePrint molecular subtype categories with IHC-based subtype classification.

   Time frame: Baseline. First study visit.