Trial Outcomes & Findings for Personalized Treatment Selection for Metastatic Breast Cancer (NCT NCT00780676)

Last Updated: 2020-09-03

Results Overview

Rate of participants with response complete, partial response or stable disease categorized by Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Radiological response assessments must be repeated every 8 weeks during therapy.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

97 participants

Primary outcome timeframe

Tumor status assessed every 8 weeks during therapy, up to 6 months

Results posted on

2020-09-03

Participant Flow

Recruitment Period: June 10, 2009 to July 25, 2012. All recruitment performed at The University of Texas MD Anderson Cancer Center.

Of the 97 participants recruited, 67 were excluded from the trial before assignment to groups. No participants were assigned to "MEK Pathway Activity Predictor Positive" and "MEK Pathway Predictor Negative" Arms/Groups.

Participant milestones

Participant milestones
Measure	Dasatinib Sensitivity Signature Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.	SRC Pathway Activity Signature Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.	Dasatinib Target Index Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
Overall Study STARTED	9	8	13
Overall Study COMPLETED	9	8	13
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Personalized Treatment Selection for Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dasatinib Sensitivity Signature n=9 Participants Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.	SRC Pathway Activity Signature n=8 Participants Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.	Dasatinib Target Index n=13 Participants Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.	MEK Pathway Activity Predictor Positive Participants predicted to respond to selumetinib/AZD6244 by predictive gene signature (either MEK pathway activity predictor positive or MEK pathway predictor negative) receive selumetinib 75 mg by mouth twice daily (BID).	MEK Pathway Predictor Negative Participants predicted to respond to selumetinib/AZD6244 by predictive gene signature (MEK pathway predictor negative) receive selumetinib 75 mg by mouth twice daily (BID).	Total n=30 Participants Total of all reporting groups
Age, Continuous	46.5 years n=5 Participants	51.6 years n=7 Participants	54.3 years n=5 Participants	—	—	51 years n=10 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants	—	—	30 Participants n=10 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	—	0 Participants n=10 Participants
Region of Enrollment United States	9 participants n=5 Participants	8 participants n=7 Participants	13 participants n=5 Participants	—	—	30 participants n=10 Participants

PRIMARY outcome

Timeframe: Tumor status assessed every 8 weeks during therapy, up to 6 months

Population: Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to either group, and only treated participants (30) included in analysis.

Outcome measures

Outcome measures
Measure	Dasatinib Sensitivity Signature n=9 Participants Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.	SRC Pathway Activity Signature n=8 Participants Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.	Dasatinib Target Index n=13 Participants Participants predicted to respond to Dasatinib (Sprycel) by predictive gene signature receive dasatinib 100 mg by mouth daily.
Clinical Benefit (CB) Rate (CB = Participants With Objective Tumor Response or Stable Disease > 6 Months)	0 Percentage of Participants	0 Percentage of Participants	7.7 Percentage of Participants

Adverse Events

Dasatinib 100 mg

Serious events: 3 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dasatinib 100 mg n=30 participants at risk Participants with one of 3 predictive gene signatures (dasatinib sensitivity signature, SRC pathway activity signature and dasatinib target index) received Dasatinib 100 mg orally daily.
General disorders Hematoma following biopsy	3.3% 1/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
General disorders Death	6.7% 2/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Infections and infestations Infection, Tumor wound	3.3% 1/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.

Other adverse events

Other adverse events
Measure	Dasatinib 100 mg n=30 participants at risk Participants with one of 3 predictive gene signatures (dasatinib sensitivity signature, SRC pathway activity signature and dasatinib target index) received Dasatinib 100 mg orally daily.
Gastrointestinal disorders Abdominal pain	3.3% 1/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Blood and lymphatic system disorders Activated partial thromboplastin time prolonged	3.3% 1/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Metabolism and nutrition disorders Alanine aminotransferase increased	10.0% 3/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Metabolism and nutrition disorders Alkaline phosphatase increased	10.0% 3/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Skin and subcutaneous tissue disorders Alopecia	6.7% 2/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Gastrointestinal disorders Anorexia	3.3% 1/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Psychiatric disorders Anxiety	3.3% 1/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Musculoskeletal and connective tissue disorders Arthritis	3.3% 1/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Metabolism and nutrition disorders Aspartate aminotransferase increased	13.3% 4/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Musculoskeletal and connective tissue disorders Bone pain	3.3% 1/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Cardiac disorders Chest pain	3.3% 1/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
General disorders Chills	3.3% 1/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Psychiatric disorders Cognitive disturbance	3.3% 1/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Gastrointestinal disorders Constipation	3.3% 1/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
General disorders Constitutional Symptoms	3.3% 1/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Respiratory, thoracic and mediastinal disorders Cough	3.3% 1/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Skin and subcutaneous tissue disorders Rash	3.3% 1/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Gastrointestinal disorders Diarrhea	16.7% 5/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Skin and subcutaneous tissue disorders Dry skin	3.3% 1/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Respiratory, thoracic and mediastinal disorders Dyspnea	23.3% 7/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
General disorders Edema limbs	13.3% 4/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
General disorders Fatigue	43.3% 13/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
General disorders Fever	6.7% 2/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Gastrointestinal disorders Gastrointestinal, Sore Mouth	6.7% 2/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Nervous system disorders Headache	13.3% 4/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Blood and lymphatic system disorders Hemoglobin decreased	40.0% 12/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Reproductive system and breast disorders Hot flashes	3.3% 1/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Infections and infestations Infection, Cellulitis	6.7% 2/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Musculoskeletal and connective tissue disorders Joint pain	6.7% 2/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Blood and lymphatic system disorders Leukopenia	16.7% 5/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Blood and lymphatic system disorders Lymphopenia	13.3% 4/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Metabolism and nutrition disorders Metabolic/Laboratory (other), hyperglycemia	3.3% 1/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Musculoskeletal and connective tissue disorders Musculoskeletal (Other)	3.3% 1/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Musculoskeletal and connective tissue disorders Myalgia	26.7% 8/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Gastrointestinal disorders Nausea	30.0% 9/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
General disorders Neck pain	3.3% 1/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Blood and lymphatic system disorders Neutrophil count decreased	13.3% 4/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
General disorders Pain, Left Breast	3.3% 1/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
General disorders Pain (Other)	16.7% 5/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Cardiac disorders Pain, Chest Wall	3.3% 1/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Musculoskeletal and connective tissue disorders Pain in extremity	3.3% 1/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Nervous system disorders Peripheral sensory neuropathy	10.0% 3/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Blood and lymphatic system disorders Platelet count decreased	16.7% 5/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Respiratory, thoracic and mediastinal disorders Pleural effusion	13.3% 4/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Metabolism and nutrition disorders Serum albumin decreased	3.3% 1/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Metabolism and nutrition disorders Serum cacium decreased	3.3% 1/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Metabolism and nutrition disorders Serum phosphate decreased	3.3% 1/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Metabolism and nutrition disorders Serum sodium decreased	3.3% 1/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Metabolism and nutrition disorders Serun potassium decreased	10.0% 3/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	3.3% 1/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Eye disorders Vision blurred	6.7% 2/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.
Gastrointestinal disorders Vomiting	13.3% 4/30 • Adverse event data collected with each cycle of therapy i.e. every 28 days. Overall collection period June 2009 to July 2012. Selumetinib pathway predictor groups (both MEK pathway activity predictor positive and MEK pathway predictor negative) had no patients assigned to treatment, only treated participants (30) included in analysis and adverse event reporting. Adverse event reporting was by treatment population rather than predictive groups.

Additional Information

Stacy Moulder, MD/Associate Professor, Breast Medical Oncology

University of Texas (UT) MD Anderson Cancer Center

Phone: 713-792-2360

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place