Neoadjuvant Carbo/Paclitaxel Followed by Doxorubicin/Cyclophosphamide in Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

November 7, 2017

Primary Completion Date

March 23, 2020

Study Completion Date

February 7, 2022

Conditions
Breast CancerTriple Negative Breast Cancer
Interventions
DRUG

Carboplatin

Carboplatin is a platinum compound alkylating agent which covalently binds to DNA; interferes with the function of DNA by producing interstrand DNA cross-links.

DRUG

Paclitaxel

Paclitaxel promotes microtubule assembly by enhancing the action of tubulin dimers, stabilizing existing microtubules, and inhibiting their disassembly, interfering with the late G2 mitotic phase, and inhibiting cell replication. In addition, the drug can distort mitotic spindles, resulting in the breakage of chromosomes. Paclitaxel may also suppress cell proliferation and modulate immune response.

DRUG

Doxorubicin

Inhibition of DNA and RNA synthesis by intercalation between DNA base pairs by inhibition of topoisomerase II and by steric obstruction. Doxorubicin intercalates at points of local uncoiling of the double helix. Although the exact mechanism is unclear, it appears that direct binding to DNA (intercalation) and inhibition of DNA repair (topoisomerase II inhibition) result in blockade of DNA and RNA synthesis and fragmentation of DNA. Doxorubicin is also a powerful iron chelator; the iron-doxorubicin complex can bind DNA and cell membranes and produce free radicals that immediately cleave the DNA and cell membranes.

DRUG

Cyclophosphamide

Cyclophosphamide is an alkylating agent that prevents cell division by cross-linking DNA strands and decreasing DNA synthesis. It is a cell cycle phase nonspecific agent. Cyclophosphamide also possesses potent immunosuppressive activity. Cyclophosphamide is a prodrug that must be metabolized to active metabolites in the liver.

DRUG

Pegfilgrastim

Pegfilgrastim provides growth factor support in a single dose. It stimulates bone marrow to create neutrophils for patients undergoing chemotherapy.

DRUG

Filgrastim

Filgrastim provides growth factor support in multiple doses. It stimulates bone marrow to create neutrophils for patients undergoing chemotherapy.

Trial Locations (6)

53188

ProHealth Care, Waukesha

53211

Columbia St. Mary's Cancer Center, Milwaukee

53226

Medical College of Wisconsin, Milwaukee

53792

University of Wisconsin Carbone Cancer Center, Madison

54401

Aspirus Regional Cancer Center Wausau, Wausau

61104

Swedish American Hospital, Rockford

All Listed Sponsors
lead

University of Wisconsin, Madison

OTHER

NCT03301350 - Neoadjuvant Carbo/Paclitaxel Followed by Doxorubicin/Cyclophosphamide in Breast Cancer | Biotech Hunter | Biotech Hunter