Reversing Hormone Resistance in Advanced Breast Cancer With Pazopanib

NCT01466972 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 117513NCI-2012-00494
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the clinical benefit rate at 12 weeks from the addition of pazopanib to a non-steroidal aromatase inhibitor (NSAI) (letrozole or anastrozole) in patients with hormone receptor positive advanced breast cancer progressing on the same NSAI hormone therapy.

Conditions

Breast Cancer; Breast Neoplasm

Keywords

Advanced; Breast; Cancer; Hormone Resistance; Pazopanib; anastrozole; arimidex; letrozole; femara

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinical Benefit (CB)

  For the purpose of this study, participants who obtained a complete response (CR), partial response (PR), or stable disease (SD) at 12 weeks per Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1 were defined as having a clinical benefit from the treatment. An overall response rate of 20% was considered to be clinically meaningful. All participants who take at least two weeks of study drug and the non-steroidal aromatase inhibitor were evaluated for toxicity and efficacy

  12 weeks

Secondary Outcomes (2)

• Progression Free Survival

  up to 2 years

• Number of Participants Experiencing Any Treatment-related Adverse Events (AE)

  up to 2 years

Study Arms (1)

Pazopanib in combination with a NSAI

EXPERIMENTAL

Non-randomized, open label

Drug: Pazopanib

Interventions

Pazopanib DRUG

Oral, 800mg tablet daily per cycle

Also known as: Votrient

Pazopanib in combination with a NSAI

Eligibility Criteria

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

You may qualify if:

• Subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up.
• \- Procedures conducted as a part of routine clinical management of the subject (e.g., blood count, imaging study) and obtained prior to signed informed consent may be utilized for Screening or Baseline purposes provided these tests are obtained as specified in the protocol).
• Subjects must have measurable or evaluable disease. Disease sites that are evaluable for progression but not measurable per RECIST guidelines include:
• Bone lesions
• Previously irradiated lesions
• Cutaneous manifestations (non-discreet lesions only)
• Age ≥ 18 years.
• Postmenopausal women defined by one of the criteria:
• No spontaneous menses for at least 12 months if the subject is ≥ 50 years old;
• Amenorrheic for at least 12 months if the subject is \< 50 years old, with serum estradiol within the institutional postmenopausal range;
• Bilateral oophorectomy;
• If prior hysterectomy but intact ovaries, must be ≥ 55 years old, or have serum estradiol within the postmenopausal range;
• If premenopausal, must be on a GnRH agonist (leuprolide or goserelin) with serum estradiol levels within the institutional postmenopausal range.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
• Histologically or cytologically confirmed estrogen receptor (ER) and/or progesterone receptor (PgR) positive carcinoma of the breast with unresectable, locally advanced and/or metastatic (AJCC Stage IV) disease.

You may not qualify if:

• Prior use of pazopanib
• Premenopausal levels of estradiol, or ongoing menses (see definitions of menopause above).
• Known central nervous system (CNS) metastases or leptomeningeal carcinomatosis. Screening with CNS imaging studies (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) is required only if the subject has clinical findings suggestive of CNS metastasis.
• History of another active malignancy. Note: Subjects who have had another malignancy and have been disease-free for 5 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
• Clinically significant gastrointestinal abnormalities which might interfere with oral dosing, including, but not limited to:
• Malabsorption syndrome
• Major resection of the stomach or small bowel that could affect the absorption of study drug
• Inflammatory bowel disease
• Ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation
• History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment
• Presence of uncontrolled infection.
• Prolongation of corrected QT interval (QTc) \>480msecs.
• History of any one or more of the following cardiovascular conditions within the past 6 months:
• Angioplasty or stenting
• Myocardial infarction

Sponsors & Collaborators

• Hope Rugo, MD: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

pazopanib

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Hope Rugo, MD
• Organization: University of California, San Francisco

Hope.Rugo@ucsf.edu

(415) 353-7070

Study Officials

• Hope Rugo, M.D.

  University of California, San Francisco

  STUDY CHAIR

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 Professor

Study Record Dates

• First Submitted: October 25, 2011
• First Posted: November 8, 2011
• Study Start: April 27, 2012
• Primary Completion: December 7, 2015
• Study Completion: October 2, 2019
• Last Updated: July 8, 2020
• Results First Posted: June 16, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)