Purpose

This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.

Category

IRB Number
20150697HU
NCT Number
NCT02488967
Open to Enrollment
Yes
Sponsor
NRG Oncology -



Study Contact

Principal Investigator
Virginia Kaklamani

Regulatory Point of Contact
Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu

Regulatory Point of Contact
Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu

Regulatory Point of Contact
Virginia Kaklamani
(210) 450-3838
kaklamani@uthscsa.edu

Regulatory Point of Contact
Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu

Regulatory Point of Contact
Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu

Regulatory Point of Contact
Regulatory Staff
regaffstaff@uthscsa.edu

Regulatory Point of Contact
Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu

Regulatory Point of Contact
Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu

Regulatory Point of Contact
Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu



Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      Phase 3
      Study Type
      Interventional
      Allocation
      Randomized
      Intervention Model
      Parallel Assignment
      Primary Purpose
      Treatment
      Masking
      None (Open Label)
      Condition
    1. Breast Adenocarcinoma
    2. Estrogen Receptor Negative
    3. HER2/Neu Negative
    4. Progesterone Receptor Negative
    5. Stage IB Breast Cancer
    6. Stage IIA Breast Cancer
    7. Stage IIB Breast Cancer
    8. Stage IIIA Breast Cancer
    9. Stage IIIC Breast Cancer
    10. Triple-Negative Breast Carcinoma
    11. Arm Groups

      ArmDescriptionIntervention
      Active Comparator

      Arm I (AC-->WP)

      Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive paclitaxel IV over 60 minutes on day 1. Treatment repeats weekly for 12 courses in the absence of disease progression or unacceptable toxicity.
    12. Drug: Doxorubicin Hydrochloride

      Given IV

      Other names:

      • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
      • ADM

      • Drug: Paclitaxel

        Given IV

        Other names:

        • Anzatax
        • Asotax
        • Bristaxol
        • Praxel
        • Taxol
        • Taxol Konzentrat

      • Drug: Cyclophosphamide

        Given IV

        Other names:

        • (-)-Cyclophosphamide
        • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
        • Carloxan
        • Ciclofosfamida
        • Ciclofosfamide
        • Cicloxal
        • Clafen <

      • Other: Laboratory Biomarker Analysis

        Correlative studies

    13. Experimental

      Arm II (AC-->WP + carboplatin)

      Patients receive doxorubicin hydrochloride and cyclophosphamide as in Arm I. Patients then receive paclitaxel IV over 60 minutes on days 1, 8, and 15 and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
    14. Drug: Carboplatin

      Given IV

      Other names:

      • Blastocarb
      • Carboplat
      • Carboplatin Hexal
      • Carboplatino
      • Carbosin
      • Carbosol
      • Carbotec
      • CBDCA
      • Displata
      • Ercar
      • JM-8
      • Nealorin
      • Novoplatinum
      • Para

    15. Drug: Doxorubicin Hydrochloride

      Given IV

      Other names:

      • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
      • ADM

      • Drug: Paclitaxel

        Given IV

        Other names:

        • Anzatax
        • Asotax
        • Bristaxol
        • Praxel
        • Taxol
        • Taxol Konzentrat

      • Drug: Cyclophosphamide

        Given IV

        Other names:

        • (-)-Cyclophosphamide
        • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
        • Carloxan
        • Ciclofosfamida
        • Ciclofosfamide
        • Cicloxal
        • Clafen <

      • Other: Laboratory Biomarker Analysis

        Correlative studies