Trial Outcomes & Findings for Pegylated Liposomal Doxorubicin Hydrochloride and Carboplatin Followed by Surgery and Paclitaxel in Treating Patients With Triple Negative Stage II-III Breast Cancer (NCT NCT02315196)

Last Updated: 2023-03-29

Results Overview

The pCR rate will first be determined as proportions and calculating its 95% confidence interval. To study the association between pCR response (yes/no) and the presence of gross residual disease, type and number of mutations, clinical lymph node status (positive/negative), tumor size (\< 2 cm/\>= 2 cm) based on p53, logistic regression analysis will be used, controlling for cancer treatment and disease stage and other covariates if numbers allow.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

62 participants

Primary outcome timeframe

Disease was evaluated at baseline to after four cycles every 28 days and then after twelve weeks of treatment after surgery (up to 28 weeks from baseline).

Results posted on

2023-03-29

Participant Flow

62 participants were enrolled, nine participants withdrew consent either prior to treatment or completion of neoadjuvant therapy and or surgery.

Participant milestones

Participant milestones
Measure	Treatment (Doxil, Carboplatin, Surgery, Paclitaxel) Participants received 4 cycles of neoadjuvant Lipposomal doxorubicin (DOX)+Carboplatin(CAR) administered every 28 days, followed by definitive breast surgery and adjuvant paclitaxel 80 mg/m2 administered weekly
Overall Study STARTED	62
Overall Study COMPLETED	53
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Doxil, Carboplatin, Surgery, Paclitaxel) Participants received 4 cycles of neoadjuvant Lipposomal doxorubicin (DOX)+Carboplatin(CAR) administered every 28 days, followed by definitive breast surgery and adjuvant paclitaxel 80 mg/m2 administered weekly
Overall Study Withdrew consent	9

Baseline Characteristics

Pegylated Liposomal Doxorubicin Hydrochloride and Carboplatin Followed by Surgery and Paclitaxel in Treating Patients With Triple Negative Stage II-III Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Doxil, Carboplatin, Surgery, Paclitaxel) n=53 Participants NEOADJUVANT: Patients receive pegylated liposomal doxorubicin hydrochloride\* IV over 90 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. ADJUVANT: Patients undergo definitive surgery at the discretion of the treating physician. Patients then receive paclitaxel IV over 60 minutes once weekly for 12 weeks in the absence of disease progression or unacceptable toxicity. \*NOTE: If there is a shortage of pegylated liposomal doxorubicin hydrochloride, patients receive epirubicin hydrochloride IV over 15-20 minutes on day 1. pegylated liposomal doxorubicin hydrochloride: Given IV epirubicin hydrochloride: Given IV carboplatin: Given IV therapeutic conventional surgery: Undergo definitive surgery paclitaxel: Given IV laboratory biomarker analysis: Correlative studies quality-of-life assessment: Ancillary studies
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants
Age, Categorical >=65 years	25 Participants n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	13 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	53 participants n=5 Participants

PRIMARY outcome

Timeframe: Disease was evaluated at baseline to after four cycles every 28 days and then after twelve weeks of treatment after surgery (up to 28 weeks from baseline).

Outcome measures

Outcome measures
Measure	Treatment (Doxil, Carboplatin, Surgery, Paclitaxel) n=53 Participants Participants received 4 cycles of neoadjuvant liposomal doxorubicin (DOX)+carboplatin (CAR) administered every 28 days, followed by definitive breast surgery and adjuvant paclitaxel 80 mg/m2 administered weekly.
Rate of Pathologic Complete Response (pCR) Based on Response Evaluation Criteria in Solid Tumors Criteria	16 Participants

SECONDARY outcome

Timeframe: Time from initiation of chemotherapy until death from any cause, assessed up to 20 years

Survival functions will be computed using the Kaplan-Meier method, and compared between mutation status using the log-rank test. Adjustment for additional covariates, such as cancer treatment and disease stage, will be performed using Cox proportional hazards regression analysis if numbers allow.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from initiation of chemotherapy until death from any cause, assessed up to 20 yearsUp to 20 years

The Cox model analysis will be used to study the association between cancer recurrence and the presence of specific mutations with IHC parameters, e.g. p53, Ki67, apoptotic markers (cleaved caspase 3), phosphorylated proteins in targeted pathways, gamma-H2A histone family, member X for deoxyribonucleic acid damage. All test procedures will be done at significance level 5%. It will be determined which tumors with gross residual disease are sensitive to targeted agent, cytotoxins, or the combination as a function of mutational profile and will be tested for additive and synergistic effects.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Doxil, Carboplatin, Surgery, Paclitaxel)

Serious events: 22 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Doxil, Carboplatin, Surgery, Paclitaxel) n=53 participants at risk Participants received 4 cycles of neoadjuvant DOX+CAR administered every 28 days, followed by definitive breast surgery and adjuvant paclitaxel 80 mg/m2 administered weekly.
Blood and lymphatic system disorders febrile neutropenia	1.9% 1/53 • Number of events 1 • Disease was evaluated at baseline to after four cycles every 28 days and then after twelve weeks of treatment after surgery (up to 28 weeks from baseline).
Blood and lymphatic system disorders Neutropenia	30.2% 16/53 • Number of events 20 • Disease was evaluated at baseline to after four cycles every 28 days and then after twelve weeks of treatment after surgery (up to 28 weeks from baseline).
Blood and lymphatic system disorders Thrombocytopenia	3.8% 2/53 • Number of events 3 • Disease was evaluated at baseline to after four cycles every 28 days and then after twelve weeks of treatment after surgery (up to 28 weeks from baseline).
Gastrointestinal disorders Pruritis	1.9% 1/53 • Number of events 5 • Disease was evaluated at baseline to after four cycles every 28 days and then after twelve weeks of treatment after surgery (up to 28 weeks from baseline).
Infections and infestations Mucositis	3.8% 2/53 • Number of events 7 • Disease was evaluated at baseline to after four cycles every 28 days and then after twelve weeks of treatment after surgery (up to 28 weeks from baseline).

Other adverse events

Other adverse events
Measure	Treatment (Doxil, Carboplatin, Surgery, Paclitaxel) n=53 participants at risk Participants received 4 cycles of neoadjuvant DOX+CAR administered every 28 days, followed by definitive breast surgery and adjuvant paclitaxel 80 mg/m2 administered weekly.
General disorders Fatigue	94.3% 50/53 • Number of events 79 • Disease was evaluated at baseline to after four cycles every 28 days and then after twelve weeks of treatment after surgery (up to 28 weeks from baseline).
Blood and lymphatic system disorders Anemia	83.0% 44/53 • Number of events 110 • Disease was evaluated at baseline to after four cycles every 28 days and then after twelve weeks of treatment after surgery (up to 28 weeks from baseline).
General disorders Alopecia	18.9% 10/53 • Number of events 16 • Disease was evaluated at baseline to after four cycles every 28 days and then after twelve weeks of treatment after surgery (up to 28 weeks from baseline).

Additional Information

Deborah L Toppmeyer, MD

Cancer Institute of New Jersey

Phone: 732-235-6789

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place