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An Open-Label, Randomised Phase 1b/2 Study Of PF-04691502 In Combination With Letrozole Compared With Letrozole Alone In Patients With Estrogen Receptor Positive, Her-2 Negative Early Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Early Breast Cancer (Phase 2), Advanced Breast Cancer (Phase 1b)

Thank you

Trial Information

An Open-Label, Randomised Phase 1b/2 Study Of PF-04691502 In Combination With Letrozole Compared With Letrozole Alone In Patients With Estrogen Receptor Positive, Her-2 Negative Early Breast Cancer


The study was prematurely discontinued on 09Oct2012 due to the tolerability findings in 2
clinical studies testing PF-04691502 that have prompted the Sponsor to re-evaluate the
strategic goals of the program. In the study B1271003 an unexpected frequency of severe
skin toxicity was observed and in the study B1271004 5 cases of drug induced pneumonitis
were reported.


Inclusion Criteria:



- Phase 1 - Postmenopausal women with diagnosis of breast cancer, metastatic disease or
locally advanced disease / Estrogen Receptor positive and HER-2 negative / candidate
to receive Letrozole

- Phase 2 - Postmenopausal women with newly diagnosed primary breast cancer / Estrogen
Receptor positive and HER-2 negative / Ki-67 levels >10% positive cells

- Phase 1 & 2 - Glucose control, adequate bone marrow, liver, renal, and cardiac
function

Exclusion Criteria:

- Inflammatory carcinoma / Prior therapy with an agent active on PI3K and/or mTOR /
Significant gastrointestinal abnormalities, which may impair intake, transit or
absorption of the study drugs / Current or anticipated need for food or drugs that
are known inhibitors or inducers of CYP3A4

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Change in biopsied tumor tissue from Baseline in Ki-67 (% positive tumor cells) at 6 weeks (Phase 2)

Outcome Time Frame:

Baseline and Week 6

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United Kingdon: Medicines and Healthcare Products Regulatory Agency

Study ID:

B1271003

NCT ID:

NCT01430585

Start Date:

March 2012

Completion Date:

December 2012

Related Keywords:

  • Early Breast Cancer (Phase 2)
  • Advanced Breast Cancer (Phase 1b)
  • Ki-67
  • postmenopausal early breast cancer
  • ER positive/HER2 negative early breast cancer
  • Breast Neoplasms

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