Trial Outcomes & Findings for Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer (NCT NCT00542191)

Results Overview

Pathologic measurement post-surgery viable primary tumor mass

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Upon completion therapy after surgery

Results posted on

2021-05-26

Participant milestones
Measure	Phase II Trial Neoadjuvant Metronomic AC Followed by TC Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin: DOXORUBICIN 24mg/m2 IV plus CYCLOPHOSPHAMIDE 60mg/m2 PO weekly x 12 successive weeks followed by PACLITAXEL 80mg/m2 IV over 1 hour plus CARBOPLATIN AUC 2 IV weekly x 12 successive weeks Definitive Surgery: Standard of care definitive surgery as determined by medical provider Radiotherapy: Standard of care RADIATION THERAPY as indicated
Overall Study STARTED	21
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	3

Reasons for withdrawal
Measure	Phase II Trial Neoadjuvant Metronomic AC Followed by TC Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin: DOXORUBICIN 24mg/m2 IV plus CYCLOPHOSPHAMIDE 60mg/m2 PO weekly x 12 successive weeks followed by PACLITAXEL 80mg/m2 IV over 1 hour plus CARBOPLATIN AUC 2 IV weekly x 12 successive weeks Definitive Surgery: Standard of care definitive surgery as determined by medical provider Radiotherapy: Standard of care RADIATION THERAPY as indicated
Overall Study Death	3

Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer

Baseline characteristics by cohort
Measure	Single Arm Study; Taxol, XRT, Gemzar and Carbo n=21 Participants Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin: DOXORUBICIN 24mg/m2 IV plus CYCLOPHOSPHAMIDE 60mg/m2 PO weekly x 12 successive weeks followed by PACLITAXEL 80mg/m2 IV over 1 hour plus CARBOPLATIN AUC 2 IV weekly x 12 successive weeks Definitive Surgery: Standard of care definitive surgery as determined by medical provider Radiotherapy: Standard of care RADIATION THERAPY as indicated
Age, Continuous	50 years n=93 Participants
Sex: Female, Male Female	21 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants

Timeframe: Upon completion therapy after surgery

Population: Study closed to accrual - not enough participants to participate.

Pathologic measurement post-surgery viable primary tumor mass

Outcome measures
Measure	Single Arm Study; Taxol, XRT, Gemzar and Carbo n=18 Participants Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin: DOXORUBICIN 24mg/m2 IV plus CYCLOPHOSPHAMIDE 60mg/m2 PO weekly x 12 successive weeks followed by PACLITAXEL 80mg/m2 IV over 1 hour plus CARBOPLATIN AUC 2 IV weekly x 12 successive weeks Definitive Surgery: Standard of care definitive surgery as determined by medical provider Radiotherapy: Standard of care RADIATION THERAPY as indicated
1) Pathologic Response	15 Participants

Serious events: 3 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events
Measure	Single Arm Study; Taxol, XRT, Gemzar and Carbo n=21 participants at risk Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin: DOXORUBICIN 24mg/m2 IV plus CYCLOPHOSPHAMIDE 60mg/m2 PO weekly x 12 successive weeks followed by PACLITAXEL 80mg/m2 IV over 1 hour plus CARBOPLATIN AUC 2 IV weekly x 12 successive weeks Definitive Surgery: Standard of care definitive surgery as determined by medical provider Radiotherapy: Standard of care RADIATION THERAPY as indicated
Infections and infestations sepsis	9.5% 2/21 • Number of events 2 • Upon completion neoadjuvant chemotherapy and surgery
Respiratory, thoracic and mediastinal disorders pulmonary embolus	4.8% 1/21 • Number of events 1 • Upon completion neoadjuvant chemotherapy and surgery

Adverse event data not reported

Leo W. Jenkins Cancer Center

Phone: 252-744-1015