ER Positive, HER2 Negative Breast CancerPhase 2NCT01709370
Letrozole and CDK 4/6 Inhibitor for ER Positive, HER2 Negative Breast Cancer in Postmenopausal Women
A Phase 2 study testing Letrozole, PD 0332991 in people with ER Positive, HER2 Negative Breast Cancer, run by Organisation for Oncology and Translational Research at 1 site in China.
Trial summary
This is a phase II study evaluating the efficacy and safety of the pre-operative use of letrozole plus PD 0332991 (combination therapy) Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- ER Positive, HER2 Negative Breast Cancer
- What is being tested?
- Letrozole, PD 0332991
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- Feb 2012to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women
- Primary tumor greater than 2 cm in diameter
- Histologically proven invasive breast cancer
- Positive estrogen receptor
- Negative HER-2 receptor
- ECOG performance status ≤ 1 or Karnofsky performance status ≥ 70%
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- 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
Who cannot join
- 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
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- 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
- Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
Trial locations and contacts
1 site in 1 country.
Louis Chow, MD contact
China1 site, 1 recruiting
- Recruiting
Unimed Medical Institute
Hong Kong
Louis Chow, MD, (852)28610286
Louis Chow, MD
About this study
Official title: Phase II Neoadjuvant Study of Letrozole in Combination With PD0332991 (Oral CDK 4/6 Inhibitor) for ER Positive, HER2 Negative Breast Cancer in Postmenopausal Women
This is a phase II study evaluating the efficacy and safety of the pre-operative use of letrozole plus PD 0332991 (combination therapy)
- Conditions
- ER Positive, HER2 Negative Breast Cancer
- Being tested
- Letrozole, PD 0332991
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letrozole, PD 0332991Drug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Letrozole, PD 0332991 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rates
Measured: Every 4 weeks before surgery
Secondary outcomes (1)
Number of Participants with Adverse Events
Measured: Continuous during the study, up to 28 days after the last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ER Positive, HER2 Negative Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Organisation for Oncology and Translational Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709370
- Sponsor's protocol ID
- OOTR-N007/LET-CDK
- Status last verified
- Oct 2012
- First submitted
- 15 Oct 2012
- Last updated
- 31 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Neoadjuvant Study of Letrozole in Combination With PD0332991 (Oral CDK 4/6 Inhibitor) for ER Positive, HER2 Negative Breast Cancer in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01709370
- Acronym / sponsor ID
- OOTR-N007/LET-CDK
- Conditions
- ER Positive, HER2 Negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Organisation for Oncology and Translational ResearchUniversity, hospital or other
- Study start
- Feb 2012
- First posted
- 18 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II study evaluating the efficacy and safety of the pre-operative use of letrozole plus PD 0332991 (combination therapy)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Letrozole plus PD 0332991 | Experimental | Drug: Letrozole, PD 0332991Drug: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Postmenopausal women
- Primary tumor greater than 2 cm in diameter
- Histologically proven invasive breast cancer
- Positive estrogen receptor
- Negative HER-2 receptor
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Letrozole, PD 0332991 | Drug | Letrozole plus PD 0332991 |
Primary outcome
Objective response rates
Time frame: Every 4 weeks before surgery
1 secondary outcome
Number of Participants with Adverse Events
Time frame: Continuous during the study, up to 28 days after the last treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis Chow, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Letrozole, PD 0332991 in people with ER Positive, HER2 Negative Breast Cancer, run by Organisation for Oncology and Translational Research at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louis Chow, MD ((852)28610286), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rates (time frame: Every 4 weeks before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2013.