Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2021-005735-22 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this clinical trial is to provide study medicine(s) and learn about their safety. This study is seeking participants who:
Participants in this study will continue to receive treatment as they were in the parent study. The time by which participants will take part in this study is retrospective (after completed parent study). We will examine the experiences of people receiving the study medicine(s). This will help us determine if the study medicine(s) are safe. During this time, the participants will be monitored for the safety of the study medicine(s).
This is an open-label study to provide continued access to treatment for eligible participants who continue to derive clinical benefit as determined by the investigator from study intervention(s) in a Pfizer-sponsored palbociclib clinical study (Parent Study)
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Other | Cetuximab |
|
| Arm 2 | Experimental | Palbociclib plus Cetuximab |
|
| Arm 3 | Other | Palbociclib plus Fulvestrant |
|
| Arm 4 | Other | Palbociclib plus Letrozole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palbociclib | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number/Percentage of Participants with Treatment-Emergent Adverse Events (AEs) Leading to Permanent Discontinuation of Study Treatment and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Baseline up to 28 days after last dose of study intervention |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Medical Center at Mission Bay | San Francisco | California | 94158 | United States | ||
| The First Affiliated Hospital of Anhui Medical University |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cetuximab | Drug | Intravenous (IV) infusion |
|
| Fulvestrant | Drug | Intramuscular (IM) |
|
| Letrozole | Drug | oral |
|
| Hefei |
| Anhui |
| 230022 |
| China |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| Sun Yat-sen Memorial Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510000 | China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150081 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450003 | China |
| Hubei Cancer Hospital | Wuhan | Hubei | 430079 | China |
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| Liaoning Cancer Hospital and Institute | Shenyang | Liaoning | 110042 | China |
| The First Hospital of China Medical University | Shenyang | Liaoning | 110167 | China |
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
| Cancer Hospital Chinese Academy of Medical Science | Beijing | 100021 | China |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey | Nuevo León | 64460 | Mexico |
| National Cancer Center | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| Samsung Medical Center | Seoul | Seoul-teukbyeolsi [seoul] | 06351 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| National Cheng Kung University Hospital | Tainan | 704302 | Taiwan |
| Mackay Memorial Hospital | Taipei | 10449 | Taiwan |
| Faculty of Medicine, Ramathibodi Hospital, Mahidol University | Ratchathewi | Bangkok | 10400 | Thailand |
| Department of Medicine, Faculty of Medicine Siriraj Hospital | Bangkok | 10700 | Thailand |
| Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" | Chernivtsi | Chernivetska Oblast | 58013 | Ukraine |
| Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council | Dnipro | 49102 | Ukraine |
| Municipal non-profit enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council | Ivano-Frankivsk | 76000 | Ukraine |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C500026 | palbociclib |
| D000068818 | Cetuximab |
| D000077267 | Fulvestrant |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided