Trial Outcomes & Findings for Lapatinib Ditosylate and Radiation Therapy in Treating Patients With Locally Advanced or Locally Recurrent Breast Cancer (NCT NCT01868503)

Results Overview

Complete clinical response will be defined as the absence of tumor on the chest wall, in the treated breast, or in the nodal regions as assessed by clinical examination +/- radiographic imaging (if clinically indicated).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

Up to 12 weeks

Results posted on

2017-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Lapatinib Ditosylate, Radiation Therapy) Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks. lapatinib ditosylate: Given PO radiation therapy: Undergo radiation therapy laboratory biomarker analysis: Correlative studies
Overall Study STARTED	7
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Lapatinib Ditosylate, Radiation Therapy) Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks. lapatinib ditosylate: Given PO radiation therapy: Undergo radiation therapy laboratory biomarker analysis: Correlative studies
Overall Study Withdrawal by Subject	1
Overall Study Protocol Violation	1

Baseline Characteristics

Lapatinib Ditosylate and Radiation Therapy in Treating Patients With Locally Advanced or Locally Recurrent Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Lapatinib Ditosylate, Radiation Therapy) n=7 Participants Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks. lapatinib ditosylate: Given PO radiation therapy: Undergo radiation therapy laboratory biomarker analysis: Correlative studies
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 weeks

Complete clinical response will be defined as the absence of tumor on the chest wall, in the treated breast, or in the nodal regions as assessed by clinical examination +/- radiographic imaging (if clinically indicated).

Outcome measures

Outcome measures
Measure	Lapatinib Plus Radiation Therapy n=7 Participants Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks and will have their blood banked for laboratory biomarker analysis. lapatinib ditosylate: Given PO radiation therapy: Undergo radiation therapy laboratory biomarker analysis: Correlative studies
Percentage of Patients Achieving Complete Clinical Response	2 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Data were not collected and the outcome measure was not analyzed.

Defined as the percentage of biopsy specimens for which the SCGEP assay achieves a non-zero number.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: This outcome was not analyzed due to lack of funding. It may be re-evaluated in the future. Data were not collected and the outcome measure was not analyzed.

Defined as the difference between the percentage of BCSCs before and after treatment. Proportion of biopsy samples that are evaluable for BCSCs will be estimated along with 95% exact confidence intervals. BCSC results will be summarized using medians and interquartile ranges. Changes in BCSCs will be assessed using the Wilcoxon signed rank test.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Participants enrolled in the study.

Adverse events will be tabulated by organ system and severity.

Outcome measures

Outcome measures
Measure	Lapatinib Plus Radiation Therapy n=7 Participants Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks and will have their blood banked for laboratory biomarker analysis. lapatinib ditosylate: Given PO radiation therapy: Undergo radiation therapy laboratory biomarker analysis: Correlative studies
Incidence of Adverse Events Graded According to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Grade 3 Events	2 incidencts
Incidence of Adverse Events Graded According to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 Grade 4 Events	1 incidencts

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Of the patients in the treatment arm, only 1 received surgery.

Proportion of patients who achieve a pathological complete response will be estimated with 95% exact confidence intervals.

Outcome measures

Outcome measures
Measure	Lapatinib Plus Radiation Therapy n=1 Participants Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks and will have their blood banked for laboratory biomarker analysis. lapatinib ditosylate: Given PO radiation therapy: Undergo radiation therapy laboratory biomarker analysis: Correlative studies
Pathologic Complete Response Rate for Those Patients Undergoing Surgical Resection Defined as no Evidence of Residual Tumor in the Breast and Lymph Nodes	0 Participants

Adverse Events

Treatment (Lapatinib Ditosylate, Radiation Therapy)

Serious events: 3 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Lapatinib Ditosylate, Radiation Therapy) n=7 participants at risk Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks. lapatinib ditosylate: Given PO radiation therapy: Undergo radiation therapy laboratory biomarker analysis: Correlative studies
Blood and lymphatic system disorders Lymphocyte count decreased	14.3% 1/7 • Number of events 1
Blood and lymphatic system disorders Anemia	14.3% 1/7 • Number of events 1
Infections and infestations Fever-Possible sepsis	14.3% 1/7 • Number of events 1
Vascular disorders Chest Pain	14.3% 1/7

Other adverse events

Other adverse events
Measure	Treatment (Lapatinib Ditosylate, Radiation Therapy) n=7 participants at risk Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks. lapatinib ditosylate: Given PO radiation therapy: Undergo radiation therapy laboratory biomarker analysis: Correlative studies
Endocrine disorders Alanine aminotransferase increased	14.3% 1/7 • Number of events 2

Additional Information

Dr. Kathleen Horst

Stanford University

Phone: 6507360921

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place