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Clinical Trials/EUCTR2013-000568-28-BE
EUCTR2013-000568-28-BE
Active, not recruiting
Phase 1

A phase II randomized, double-blind study of neoadjuvant letrozole plus GDC-0032 versus letrozole plus placebo in postmenopausal women with ER-positive/HER2-negative, early stage breast cancer

Genentech, Inc.0 sites330 target enrollmentMay 6, 2014
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ConditionsWOMEN WITH ER-POSITIVE/HER2-NEGATIVE, EARLY STAGE BREAST CANCERMedDRA version: 18.0Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsFemara 2,5 mg, FilmtablettenLetrozole 2.5 mg Film-coated TabletsLetrozol-Actavis 2,5 mg Filmtabletten

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
WOMEN WITH ER-POSITIVE/HER2-NEGATIVE, EARLY STAGE BREAST CANCER
Sponsor
Genentech, Inc.
Enrollment
330
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 6, 2014
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Histologically confirmed invasive breast carcinoma, with all of the following characteristics:
  • •– Primary tumor \= 2 cm in largest diameter (cT1\-3\) by MRI. In the case of a multifocal tumor (defined as the presence of two or more foci of cancer within the same breast quadrant), the largest lesion must be \= 2 cm and designated as the target” lesion for all subsequent tumor evaluations.
  • •– Stage I to operable Stage III breast cancer
  • •– Documentation confirming the absence of distant metastasis (M0\) as
  • •determined by institutional practice (in patients where there may be a
  • •reasonable suspicion of advanced disease e.g., large tumors, clinically positive axillary lymph nodes, signs and symptoms).
  • •ER\-positive and HER2\-negative breast cancer, as per local laboratory or regional definition
  • •Breast cancer eligible for primary surgery
  • •Tumor tissue from FFPE core biopsy of breast primary tumor that is confirmed as evaluable for PIK3CA mutation status by central histopathology laboratory
  • •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria

  • •Any prior treatment for primary invasive breast cancer
  • •Patients with cT4 or cN3 stage breast tumors
  • •Metastatic (Stage IV) breast cancer
  • •Bilateral invasive breast cancer
  • •Multicentric breast cancer (the presence of more than one tumor in different quadrants of the breast)
  • •Patients who have undergone excisional biopsy of primary tumor and/or axillary lymph nodes
  • •Patients who have undergone sentinel lymph node biopsy prior to study treatment
  • •Patients for whom upfront chemotherapy is clinically judged appropriate as optimal neoadjuvant treatment
  • •Patients for whom immediate surgery is indicated
  • •Type 1 or 2 diabetes requiring antihyperglycemic medication

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
Randomized trial in postmenopausal women with estrogen receptor-positive, HER2-negative breast cancer in the presurgical setting to test whether the addition of GDC-0032 to letrozole gives added benefitWOMEN WITH ER-POSITIVE/HER2-NEGATIVE, EARLY STAGE BREAST CANCERMedDRA version: 19.1Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2013-000568-28-CZGenentech, Inc.330
Active, not recruiting
Phase 1
A phase II randomized, double-blind study of neoadjuvant letrozole plus GDC-0032 versus letrozole plus placebo in postmenopausal women with ER-positive/HER2-negative, early stage breast cancer
EUCTR2013-000568-28-ITGenentech, Inc.334
Active, not recruiting
Phase 1
Randomized trial in postmenopausal women with estrogen receptor-positive, HER2-negative breast cancer in the presurgical setting to test whether the addition of GDC-0032 to letrozole gives added benefitWOMEN WITH ER-POSITIVE/HER2-NEGATIVE, EARLY STAGE BREAST CANCERMedDRA version: 18.0Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2013-000568-28-GBGenentech, Inc.334
Active, not recruiting
Phase 1
Randomized trial in postmenopausal women with estrogen receptor-positive, HER2-negative breast cancer in the presurgical setting to test whether the addition of GDC-0032 to letrozole gives added benefit
EUCTR2013-000568-28-PLGenentech, Inc.330
Active, not recruiting
Phase 1
Randomized trial in postmenopausal women with estrogen receptor-positive, HER2-negative breast cancer in the presurgical setting to test whether the addition of GDC-0032 to letrozole gives added benefitWOMEN WITH ER-POSITIVE/HER2-NEGATIVE, EARLY STAGE BREAST CANCERMedDRA version: 18.1 Level: LLT Classification code 10070575 Term: Estrogen receptor positive breast cancer System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2013-000568-28-PTGenentech, Inc.334