Trial Outcomes & Findings for Study Adding Multikinase Inhibitor Sorafenib to Existing Endocrine Therapy in Patients With Advanced Breast Cancer (NCT NCT00525161)

Last Updated: 2015-01-26

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Patients were followed monthly for clinical and toxicity evaluation. Disease response by RECIST criteria v1.0 was assessed after 3 months by appropriate scans and these were obtained every 2 months thereafter until progression.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

12 weeks after treatment & 8 weeks after initial documentation of response

Results posted on

2015-01-26

Participant Flow

11 patients were recruited from the University of Kentucky Markey Cancer Center from November 2009-November 2011.

Participant milestones

Participant milestones
Measure	Sorafenib & Endocrine Therapy Sorafenib \& Endocrine Therapy sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first.
Overall Study STARTED	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Sorafenib & Endocrine Therapy Sorafenib \& Endocrine Therapy sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first.
Overall Study Adverse Event	1

Baseline Characteristics

Study Adding Multikinase Inhibitor Sorafenib to Existing Endocrine Therapy in Patients With Advanced Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sorafenib & Endocrine Therapy n=11 Participants Sorafenib \& Endocrine Therapy sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first.
Age, Continuous	45 years n=5 Participants
Age, Customized <40 years	3 participants n=5 Participants
Age, Customized 40-49 years	3 participants n=5 Participants
Age, Customized 50-59 years	1 participants n=5 Participants
Age, Customized 60-69 years	2 participants n=5 Participants
Age, Customized >=70 years	2 participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Locally advanced Yes	5 participants n=5 Participants
Locally advanced No	6 participants n=5 Participants
Relapsed versus de novo metastasis de novo	7 participants n=5 Participants
Relapsed versus de novo metastasis Relapsed	4 participants n=5 Participants
Estrogen receptor status Positive	11 participants n=5 Participants
Estrogen receptor status Negative	0 participants n=5 Participants
Progesterone receptor status Positive	9 participants n=5 Participants
Progesterone receptor status Negative	2 participants n=5 Participants
Human epidermal growth factor receptor 2 (HER2) status Negative	9 participants n=5 Participants
Human epidermal growth factor receptor 2 (HER2) status Unknown	2 participants n=5 Participants
Endocrine therapy at study entry Tamoxifen	7 participants n=5 Participants
Endocrine therapy at study entry Anastrozole	1 participants n=5 Participants
Endocrine therapy at study entry Exemestane	1 participants n=5 Participants
Endocrine therapy at study entry Fulvestrant	1 participants n=5 Participants
Endocrine therapy at study entry Letrozole	1 participants n=5 Participants
Line of current endocrine therapy First-line (Primary) treatment	9 participants n=5 Participants
Line of current endocrine therapy Second-line (Subsequent) treatment	2 participants n=5 Participants
Disease status at entry Progressive Disease	8 participants n=5 Participants
Disease status at entry Stable disease with maximal response	3 participants n=5 Participants
Prior chemotherapy No	8 participants n=5 Participants
Prior chemotherapy Yes	3 participants n=5 Participants
Bone metastases Yes	9 participants n=5 Participants
Bone metastases No	2 participants n=5 Participants
Lung Metastases Yes	5 participants n=5 Participants
Lung Metastases No	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks after treatment & 8 weeks after initial documentation of response

Population: one discontinued treatment after 2 weeks owing to a grade 3 rash and was not evaluable for response

Outcome measures

Outcome measures
Measure	Sorafenib & Endocrine Therapy n=10 Participants Sorafenib \& Endocrine Therapy sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first.
Response Rate Stable Disease	7 participants
Response Rate Progression	3 participants

SECONDARY outcome

Timeframe: continuously

Outcome measures

Outcome measures
Measure	Sorafenib & Endocrine Therapy n=11 Participants Sorafenib \& Endocrine Therapy sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first.
Time to Progression	6.1 months Interval 2.6 to 11.3

SECONDARY outcome

Timeframe: 24 weeks

Clinical benefit rate is defined as complete response, partial response, or stable disease (CR/PR/SD) as measured by Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for a minimum of at least 24 weeks.

Outcome measures

Outcome measures
Measure	Sorafenib & Endocrine Therapy n=10 Participants Sorafenib \& Endocrine Therapy sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first.
Clinical Benefit Rate	50 percentage of participants Interval 19.0 to 81.0

Adverse Events

Sorafenib & Endocrine Therapy

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sorafenib & Endocrine Therapy n=11 participants at risk Sorafenib \& Endocrine Therapy sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first.
Infections and infestations Infection/Herpes Zoster	9.1% 1/11
Gastrointestinal disorders Colitis	9.1% 1/11

Other adverse events

Other adverse events
Measure	Sorafenib & Endocrine Therapy n=11 participants at risk Sorafenib \& Endocrine Therapy sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first.
Metabolism and nutrition disorders Hypophosphatemia	100.0% 11/11
Metabolism and nutrition disorders Hypokalemia	90.9% 10/11
Skin and subcutaneous tissue disorders Rash	81.8% 9/11
Investigations Weight Loss	81.8% 9/11
Vascular disorders Hypertension	54.5% 6/11
Gastrointestinal disorders Nausea/vomiting	54.5% 6/11
Investigations Elevated ALT/AST	45.5% 5/11
Metabolism and nutrition disorders Anorexia	45.5% 5/11
Gastrointestinal disorders Diarrhea	36.4% 4/11
Metabolism and nutrition disorders Hypocalcemia	36.4% 4/11
General disorders Fatigue	27.3% 3/11
Gastrointestinal disorders Mucositis	27.3% 3/11
Blood and lymphatic system disorders Leukopenia	27.3% 3/11
Blood and lymphatic system disorders Anemia	27.3% 3/11
Blood and lymphatic system disorders Thrombocytopenia	18.2% 2/11
Skin and subcutaneous tissue disorders Stevens-Johnson Syndrome	9.1% 1/11
Musculoskeletal and connective tissue disorders Joint Pain	9.1% 1/11

Additional Information

Dr. Suleiman Massarweh

University of Kentucky

Phone: 8593238043

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place