NCT01709370

UnknownPhase 2

Letrozole and CDK 4/6 Inhibitor for ER Positive, HER2 Negati...

Organisation for Oncology and Translational Research Source

Organisation for Oncology and Translational Research

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

OOTR-N007/LET-CDK

Study Type

interventional

Estimated enrollment

45

Locations

1 country

Sites

1

Timeline

Study Start

February 2012

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

Not reported

Date not reported

Brief Summary

This is a phase II study evaluating the efficacy and safety of the pre-operative use of letrozole plus PD 0332991 (combination therapy)

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 45 participants
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
February 2012
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
October 15, 2012
Actual (reported)
First Posted
October 18, 2012
Actual (reported)

Last Updated: December 31, 2013
Status Verified: October 2012
Last Update Submitted: December 29, 2013

Conditions

ER Positive, HER2 Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

Objective response rates
Every 4 weeks before surgery

Secondary Outcomes (1)

Number of Participants with Adverse Events
Continuous during the study, up to 28 days after the last treatment

Other Outcomes (1)

Pathologic response rates
At time of definitive surgery

Study Arms (1)

Letrozole plus PD 0332991

EXPERIMENTAL

Drug: Letrozole 2.5mg/d for 16 weeks before surgery plus PD 0332991 (CDK-4/6 inhibitor) 125 mg/d for 3 out of 4 weeks in repeated cycles for 16 weeks before surgery

Drug: Letrozole, PD 0332991

Interventions

Letrozole, PD 0332991Drug

Letrozole plus PD 0332991

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Postmenopausal women
Primary tumor greater than 2 cm in diameter

Sponsors & Collaborators

Organisation for Oncology and Translational Research
Otherlead

Study Sites (1)

Unimed Medical Institute

Hong Kong, China

RECRUITING

Louis Chow, MDCONTACT(852)28610286

Louis Chow, MDPRINCIPAL INVESTIGATOR

MeSH Terms

Interventions

Letrozolepalbociclib

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Louis Chow, MD

CONTACT

(852)28610286

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 15, 2012

First Posted

October 18, 2012

Study Start

February 2012

Date type not reported

This date has not been verified as actual or estimated.

Last Updated

December 31, 2013

Record last verified: 2012-10

Histologically proven invasive breast cancer

Positive estrogen receptor

Negative HER-2 receptor

ECOG performance status ≤ 1 or Karnofsky performance status ≥ 70%

Laboratory values must be follows:

Absolute neutrophil count ≥ 1,500/mm3; Platelets ≥ 100,000/mm3; Hemoglobin ≥ 9 g/dL; Bilirubin ≤ 1.5 × institutional upper limit of normal (ULN); Serum Creatinine ≤ 1.5 × ULN; Alkaline phosphatase ≤ 2 × ULN; AST and ALT ≤ 2 × ULN; Normal finding of ECG - QTc ≤ 470 msec (based on the mean value of the triplicate ECGs); Left ventricular ejection fraction (LVEF) ≥ 60%.

Able to give written informed consent form

Able to follow prescription instructions reasonably well

You may not qualify if:

Male
Severe psychiatric disorder
Prior history of other malignancy within 5 years of study entry, aside from basal cell carcinoma or the skin or carcinoma-in-situ of the uterine cervix
Locally advanced breast cancer (T3N1 or Any T4 or Any N2, N3), or distant metastasis
Multifocal or multicentric breast cancer except that the largest lesion is greater than 2cm
Major surgery within 3 weeks of first study treatment
Current use or anticipated need for:
Food or drugs that are known strong CYP3A4 inhibitors; drugs that are known strong CYP3A4 inducers
Severe cardiovascular diseases in the previous 6 months
Active inflammatory bowel disease or chronic diarrhea
Renal Impairment
Poor adrenal function
Hepatitis B and/or hepatitis C carriers (unless with normal hepatic function)
Known human immunodeficiency virus infection
Known hypersensitivity to anti-aromatase drugs or any cell cycle inhibitor
+1 more criteria

Contact the study team to confirm eligibility.

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01709370
Data provider: ClinicalTrials.gov
Source updated: 2013-12-31
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:25:48 UTC

Locations

CN(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (1)

Letrozole plus PD 0332991

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations