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A Clinical Trial to Qualify the Growth Factor Signature (GFS) as an Intermediate Biomarker of Response for Development of PI3K-Pathway Inhibitors in Patients With Breast Cancer


Phase 1
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

A Clinical Trial to Qualify the Growth Factor Signature (GFS) as an Intermediate Biomarker of Response for Development of PI3K-Pathway Inhibitors in Patients With Breast Cancer


Inclusion Criteria:



- Participant has operable Stage I-IIIa invasive breast cancer of the following
subtype: ER-positive, HER2-negative tumor with histologic grade 2 or 3 and Ki67 ≥ 15%

- Tumor is at least 2 cm in diameter as assessed by physical or radiographic exam

- Participant consents to provide an existing tissue sample or to have a core needle
biopsy before drug administration

- Participant consents to provide tissue samples following drug administration by a
second core needle biopsy or from a surgical specimen

- Participant must have adequate organ function

Exclusion Criteria:

- Participant has received any prior chemotherapy, biological therapy or radiotherapy
for breast cancer

- Participant has a known hypersensitivity to the components of study drugs or their
analogs, including hypersensitivity to macrolide antibiotics (e.g. clarithromycin,
erythromycin, azithromycin).

- Participant has poorly controlled diabetes mellitus, or requires insulin for glucose
control.

- Participant is unable to swallow capsules and/or absorb oral medications

- Participant is pregnant or breastfeeding, or expecting to conceive children within
the projected duration of the study.

- Participant is known to be Human Immunodeficiency Virus (HIV)-positive

- Participant has known history of active Hepatitis B or C.

- Participant is concurrently using growth hormone (GH) or growth hormone inhibitors

- Participant has significant or uncontrolled cardiovascular disease, including heart
failure, unstable angina, or a myocardial infarction within the last 6 months

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The population mean change from baseline in GFS (Growth Factor Signature) score

Outcome Time Frame:

Baseline and Day 15

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

8669-050

NCT ID:

NCT01220570

Start Date:

September 2010

Completion Date:

December 2012

Related Keywords:

  • Breast Cancer
  • breast cancer
  • ridaforolimus
  • ridaforolimus/dalotuzumab combination therapy
  • Breast Neoplasms

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