Advanced Breast Cancer (Female)NCT02142868
Expanded Access Study Of Palbociclib (PD-0332991) In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR-Positive, Her2-Negative Advanced Breast Cancer For Whom Letrozole Therapy Is Deemed Appropriate
A study testing Palbociclib and Letrozole in people with Advanced Breast Cancer (Female), run by Pfizer at 55 sites in 2 countries.
Trial summary
To provide access to palbociclib to post-menopausal women with HR-positive, HER2-negative advanced breast cancer who are deemed appropriate for letrozole therapy (Canada: first-line patients only). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Breast Cancer (Female)
- What is being tested?
- Palbociclib and Letrozole
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 55 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Post-menopausal women 18 years of age or above with proven diagnosis of advanced adenocarcinoma of the breast (locoregionally recurrent or metastatic disease)
- ER-positive and/or PR-positive tumor based on local laboratory results
- HER2-negative tumor based on local laboratory results
- Patients must be appropriate candidates for letrozole therapy (Canada: first-line patients only)
Who cannot join
- Patients who have previously participated in a palbociclib trial or who have received prior treatment with any CDK inhibitor
Trial locations and contacts
55 sites in 2 countries.
55 sites in 2 countries
United States44 sites
CBCC Global Research, Inc. at Comprehensive Blood & Cancer Center Research Center
Bakersfield, California, 93309
SKCCC at Johns Hopkins, The Harry and Jeannette Weinberg Building
Baltimore, Maryland, 21287
UPMC Cancer Center Beaver
Beaver, Pennsylvania, 15009
Presence Saint Joseph Hospital
Chicago, Illinois, 60657
The West Clinic, P.C.
Corinth, Mississippi, 38834
North Shore Oncology-Hematology Associates, Ltd.
Crystal Lake, Illinois, 60014
Texas Oncology -Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Gwinnett Hospital System Inc. -d/b/a - The Center for Cancer Care
Duluth, Georgia, 30096
Medical Oncology & Hematology Associates of Northern Virginia, Ltd.
Fairfax, Virginia, 22031
The West Clinic, P.C. d/b/a West Cancer Center
Germantown, Tennessee, 38138
UPMC Cancer Center Arnold Palmer at Mountainview
Greensburg, Pennsylvania, 15601
UPMC Cancer Center Greenville
Greenville, Pennsylvania, 16125
Texas Oncology - Memorial City
Houston, Texas, 77024
Jackson Oncology Associates, PLLC
Jackson, Mississippi, 39202
Mississippi Baptist Health Systems
Jackson, Mississippi, 39202
Jackson Oncology Associates, PLLC
Jackson, Mississippi, 39216
ProHealthCARE Associates, LLP
Lake Success, New York, 11042
Gwinnett Hospital System Inc. -d/b/a - The Center for Cancer Care
Lawrenceville, Georgia, 30046
North Shore Oncology-Hematology Associates, Ltd.
Libertyville, Illinois, 60048
SKCCC at Johns Hopkins, Green Spring Station
Lutherville, Maryland, 21093
The West Clinic, P.C. d/b/a West Cancer Center
Memphis, Tennessee, 38104
The West Clinic, P.C. d/b/a West Cancer Center
Memphis, Tennessee, 38120
Metairie Oncologist, LLC
Metairie, Louisiana, 70006
UPMC Cancer Center Monroeville
Monroeville, Pennsylvania, 15146
Presence Medical Group Hematology Oncology
Northbrook, Illinois, 60062
Illinois CancerCare, P.C.
Peoria, Illinois, 61615
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
UPMC Cancer Center St. Margarets
Pittsburgh, Pennsylvania, 15215
University of Pittsburgh Cancer Institute, Investigational Drug Service, William M. Cooper Pavilion
Pittsburgh, Pennsylvania, 15232
University of Pittsburgh Medical Center, William M. Cooper Pavilion, Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
UPMC Cancer Center Passavant (HOA)
Pittsburgh, Pennsylvania, 15237
UPMC Cancer Center Passavant (OHA)
Pittsburgh, Pennsylvania, 15237
Northwest Cancer Specialists dba Compass Oncology
Portland, Oregon, 97213
Northwest Cancer Specialists dba Compass Oncology
Portland, Oregon, 97225
Medical Oncology & Hematology Associates of Northern Virginia, Ltd.
Reston, Virginia, 20190
Swedish Cancer Institute
Seattle, Washington, 98104
UPMC Cancer Center Northwest
Seneca, Pennsylvania, 16346
Presence Infusion Care - Skokie
Skokie, Illinois, 60077
The West Clinic, P.C. d/b/a West Cancer Center
Southaven, Mississippi, 38671
Mount Nittany Medical Center
State College, Pennsylvania, 16803
Northwest Cancer Specialists dba Compass Oncology
Vancouver, Washington, 98683
Northwest Cancer Specialists dba Compass Oncology
Vancouver, Washington, 98684
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Washington Cancer Institute at MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Canada11 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Holy Cross Centre
Calgary, Alberta, T2S 3C3
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Queen Elizabeth II (QEII) Health Sciences Centre, Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
London Regional Cancer Program
London, Ontario, N6A 4L6
McGill University Health Centre (MUHC), Glen Site, Royal Victoria Hospital, Cedars Cancer Centre
Montreal, Quebec, H4A 3J1
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6
CHU de Quebec - Hospital du Saint-Sacrement
Québec, Quebec, G1S 4L8
Sunnybrook health Sciences Centre
Toronto, Ontario, M4N 3M5
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5
SunnyBrook Research Institute
Toronto, Ontario, M4N 3M5
About this study
Official title: AN EXPANDED ACCESS STUDY OF PALBOCICLIB IN COMBINATION WITH LETROZOLE AS TREATMENT OF POST-MENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE, HER2 NEGATIVE ADVANCED BREAST CANCER FOR WHOM LETROZOLE THERAPY IS DEEMED APPROPRIATE
To provide access to palbociclib to post-menopausal women with HR-positive, HER2-negative advanced breast cancer who are deemed appropriate for letrozole therapy (Canada: first-line patients only).
Read the detailed description
This study is currently available in Canada only.
- Conditions
- Advanced Breast Cancer (Female)
- Being tested
- Palbociclib, Letrozole
- Keywords
- Expanded Access, Advanced Breast Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalbociclibDrug
Also called Ibrance
Palbociclib will be administered orally once a day at 125 mg/day for 21 days followed by 7 days off treatment for each 28-day cycle (Schedule 3/1)
LetrozoleDrug
Also called Femara
Letrozole will be administered orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast Cancer (Female)Studies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142868
- Sponsor's protocol ID
- A5481034
- Status last verified
- Dec 2018
- First submitted
- 16 May 2014
- Last updated
- 21 Dec 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AN EXPANDED ACCESS STUDY OF PALBOCICLIB IN COMBINATION WITH LETROZOLE AS TREATMENT OF POST-MENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE, HER2 NEGATIVE ADVANCED BREAST CANCER FOR WHOM LETROZOLE THERAPY IS DEEMED APPROPRIATE
- ClinicalTrials.gov ID
- NCT02142868
- Acronym / sponsor ID
- A5481034
- Conditions
- Advanced Breast Cancer (Female)
- Keywords
- Expanded Access, Advanced Breast Cancer
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- First posted
- 20 May 2014 (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.
To provide access to palbociclib to post-menopausal women with HR-positive, HER2-negative advanced breast cancer who are deemed appropriate for letrozole therapy (Canada: first-line patients only).
Detailed description
This study is currently available in Canada only.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Post-menopausal women 18 years of age or above with proven diagnosis of advanced adenocarcinoma of the breast (locoregionally recurrent or metastatic disease)
- ER-positive and/or PR-positive tumor based on local laboratory results
- HER2-negative tumor based on local laboratory results
- Patients must be appropriate candidates for letrozole therapy (Canada: first-line patients only)
Key exclusion criteria (1 listed)
- Patients who have previously participated in a palbociclib trial or who have received prior treatment with any CDK inhibitor
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 |
|---|---|---|
| PalbociclibAlso: IbrancePalbociclib will be administered orally once a day at 125 mg/day for 21 days followed by 7 days off treatment for each 28-day cycle (Schedule 3/1) | Drug | – |
| LetrozoleAlso: FemaraLetrozole will be administered orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
55 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palbociclib and Letrozole in people with Advanced Breast Cancer (Female), run by Pfizer at 55 sites in 2 countries.
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 4 inclusion and 1 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 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, Canada. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 21 Dec 2018.