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

NCT00525161 | Terminated Phase 2 Results DMC

• 1 other identifier: 07-BRE-41-BP
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the clinical response rate to sorafenib when added to existing endocrine therapy in patients with advanced breast cancer.

Conditions

Breast Cancer

Keywords

breast cancer; Sorafenib; Nexavar; Endocrine Therapy

Outcome Measures

Primary Outcomes (1)

• Response Rate

  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.

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

Secondary Outcomes (2)

• Time to Progression

  continuously

• Clinical Benefit Rate

  24 weeks

Study Arms (1)

Sorafenib & Endocrine Therapy

EXPERIMENTAL

Sorafenib \& Endocrine Therapy

Drug: sorafenib

Interventions

sorafenib DRUG

400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first.

Also known as: Nexavar

Sorafenib & Endocrine Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects must be female.
• Age ≥ 18 years old.
• Histologically proven carcinoma of the breast.
• Estrogen receptor and/or Progesterone positive disease.
• Metastatic or locally advanced disease.
• Patients on a preexisting endocrine agent for at least 3 months before enrollment.
• Have residual measurable disease after
• maximal response to endocrine therapy or
• no response to endocrine therapy or
• progressive non-visceral disease on endocrine therapy.
• Must be able to provide a tumor block from either the primary or metastatic site, if available.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
• Adequate organ function.

You may not qualify if:

• Patients with rapidly progressive disease on endocrine therapy who would otherwise be candidates for chemotherapy.
• Other coexisting malignancies, with the exception of basal cell carcinoma or cervical carcinoma in situ.
• Prior use of anti-angiogenic agents.
• As judged by the investigator, uncontrolled intercurrent illness.
• Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
• Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
• Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort.
• Known or suspected allergy to sorafenib or any agent given in the course of this trial.
• A serious non-healing wound or ulcer.
• Evidence or history of bleeding diathesis or coagulopathy.
• Major surgery, open biopsy or significant traumatic injury within the 4 weeks prior to the first dose of the study drug.
• Pulmonary hemorrhage/bleeding event ≥ Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 within the 4 weeks prior to the first dose of study drug.
• Pregnancy
• Any condition that impairs patient's ability to swallow whole pills.
• Documented malabsorption problem.

Sponsors & Collaborators

• Suleiman Massarweh: lead
• Bayer: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Related Publications (1)

• Massarweh S, Moss J, Wang C, Romond E, Slone S, Weiss H, Karabakhtsian RG, Napier D, Black EP. Impact of adding the multikinase inhibitor sorafenib to endocrine therapy in metastatic estrogen receptor-positive breast cancer. Future Oncol. 2014 Dec;10(15):2435-48. doi: 10.2217/fon.14.99.

  PMID: 24826798 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Early termination of study due to slow accrual.

Results Point of Contact

• Title: Dr. Suleiman Massarweh
• Organization: University of Kentucky

massarweh@uky.edu

8593238043

Study Officials

• Suleiman Massarweh, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Faculty, Internal Medicine / Oncology

Study Record Dates

• First Submitted: September 3, 2007
• First Posted: September 5, 2007
• Study Start: October 1, 2007
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2015
• Last Updated: January 26, 2015
• Results First Posted: January 13, 2015

Record last verified: 2015-01

Locations

US (1)