Trial Outcomes & Findings for Preoperative Trial of Sorafenib in Combination With Cisplatin Followed by Paclitaxel for Early Stage Breast Cancer (NCT NCT01194869)

NCT ID: NCT01194869

Last Updated: 2016-10-18

Results Overview

Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. Presence of in situ cancer alone will be considered a pCR but may be recorded separately.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 25 participants
• Primary outcome timeframe: At the time of surgery, after 24 weeks of preoperative treatment
• Results posted on: 2016-10-18

Participant Flow

Patients were recruited at Winship Cancer Institute of Emory University, Emory University Hospital Midtown, and Grady Health System. The study closed to accrual in June 2015.

Participant milestones

Measure	Sorafenib Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
Overall Study STARTED	25
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Sorafenib Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
Overall Study Disease Progression	2
Overall Study Toxicity	2

Baseline Characteristics

Preoperative Trial of Sorafenib in Combination With Cisplatin Followed by Paclitaxel for Early Stage Breast Cancer

Baseline characteristics by cohort

Measure	Sorafenib n=25 Participants Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
Age, Continuous	42 years n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	12 Participants n=5 Participants
Race (NIH/OMB) White	13 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	25 participants n=5 Participants

PRIMARY outcome

Timeframe: At the time of surgery, after 24 weeks of preoperative treatment

Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. Presence of in situ cancer alone will be considered a pCR but may be recorded separately.

Outcome measures

Measure	Sorafenib n=21 Participants Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
Pathologic Complete Response (pCR) at the Time of Surgery After Preoperative Treatment	5 participants

SECONDARY outcome

Timeframe: Up to 2 years after definitive surgery

Response will be assessed according to World Health Organization criteria with progressive disease (PD) defined as a 25% or greater increase in a single lesion, OR reappearance of any lesion which has disappeared, OR clear worsening of any evaluable disease OR appearance of any new lesion/site.

Outcome measures

Measure	Sorafenib n=21 Participants Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
Clinical Response Rate During Follow-up (Disease Recurrence)	6 participants

SECONDARY outcome

Timeframe: Up to 2 years after definitive surgery

Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen during follow-up. Presence of in situ cancer alone will be considered a pCR but may be recorded separately.

Outcome measures

Measure	Sorafenib n=21 Participants Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
Clinical Response Rate (Complete Pathologic Response Rate After Surgery)	0 participants

Adverse Events

Sorafenib

Serious events: 6 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sorafenib n=25 participants at risk Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
Hepatobiliary disorders Obstructive Jaundice	4.0% 1/25
Nervous system disorders Acute Stroke	4.0% 1/25
Vascular disorders Pulmonary Embolus	4.0% 1/25
General disorders Death	8.0% 2/25
General disorders Chest Pain	4.0% 1/25

Other adverse events

Measure	Sorafenib n=25 participants at risk Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
General disorders Fatigue	76.0% 19/25
General disorders Hand-Foot Syndrome	52.0% 13/25
Vascular disorders Hypertension	44.0% 11/25
Nervous system disorders Neuropathy	36.0% 9/25

Additional Information

Elisavet Paplomata, MD

Emory University

Phone: 404-778-1900

Email: elisavet.paplomata@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place