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Phase 2 N=30 Treatment

Reversing Hormone Resistance in Advanced Breast Cancer With Pazopanib

Breast Cancer · Breast Neoplasm

Enrolled (actual)
30
Serious AEs
26.7%
Results posted
Jun 2020
Primary outcome: Primary: Number of Participants With Clinical Benefit (CB) — 13 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Pazopanib (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Hope Rugo, MD
Primary completion
Dec 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Clinical Benefit (CB)
13
SECONDARY
Progression Free Survival
20
SECONDARY
Number of Participants Experiencing Any Treatment-related Adverse Events (AE)
26

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.

Eligibility Criteria

Inclusion Criteria

  • 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 480msecs.
  • History of any one or more of the following cardiovascular conditions within the past 6 months:
  • Angioplasty or stenting
  • Myocardial infarction
  • Unstable angina
  • Coronary artery by-pass graft surgery
  • Symptomatic peripheral vascular disease
  • Class II, III or IV congestive heart failure, as defined by the New York Heart Association (NYHA).
  • Use of an investigational agent, including an investigational anti-cancer agent, within 14 days prior to the first dose of study drug.
  • Prior use of an investigational drug that targets VEGF or VEGF receptors.
  • Any ongoing toxicity from prior anti-cancer therapy that is > Grade 1 and/or that is progressing in severity.
  • Poorly controlled hypertension (defined as systolic blood pressure (SBP) of ≥140mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg).

Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. Blood pressure must be re-assessed prior to start of study therapy. The mean SBP/DBP values must be <140/90mmHg (OR 150/90mmHg, if this criterion is approved by Safety Review Team) in order for a subject to be eligible for the study.

  • History of cerebrovascular accident (CVA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.

Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulant agents for at least 6 weeks are eligible.

  • Major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer not related to cancer (procedures such as catheter placement not considered to be major).
  • Evidence of active bleeding or bleeding diathesis.
  • Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01466972). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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