Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Palbociclib

Protein Kinase Inhibitors

Enzyme Inhibitors

Observational study of Ibrance 75 mg, 100 mg and 125 mg.

Ibrance

Hormone therapy is the primary treatment option for patients with HR+ HER2- breast cancer. Despite its activity, hormone therapy is associated with initial, or more frequently acquired, resistance after exposure to one or more treatment lines.

The combination of palbociclib with hormone therapy significantly increases progression free survival (PFS) compared with hormone therapy in first and second treatment line of HR+ HER2- advanced breast cancer.

These results lead to palbociclib approval by the Food and Drug Administration (FDA) in February 2015, and European Medicines Agency (EMA) approval in November 2016 for first-line treatment of patients with metastatic HR+/HER2-breast cancer in combination with an aromatase inhibitor, and for patients who had previously received hormone therapy in combination with fulvestrant.

In Spain, palbociclib was launched last November 1st, 2017. During this period, approximately 3500 patients have received treatment with Palbociclib, and approximately a half of them in first-line treatment in combination with hormone therapy. The collection of efficacy and toxicity data in the first-line usage in the clinical practice setting is of clinical interest.

Observational Analysis of Palbociclib Treatment in Patients With First Line Therapy for Locally Advanced and/or Metastatic Breast Cancer

Observational Analysis of Treatment With Palbociclib in Patients With Locally Advanced and / or Metastatic RH + / HER 2- Breast Cancer in the First Line of Treatment Within Routine Clinical Practice.

Median time (months) from index date to death, disease progression based on radiology, laboratory evidence, pathology, or clinical assessment until next line therapy, or end of the study, whichever came first, assessed up to 52 months

Median time (months) from date of index treatment to date of death. Patients who did not die in the study period are censored at their last date in the study.

Real-world tumor response is defined as complete response or partial response, based on treating clinician's assessment of radiological evidence for change in burden of disease over the course of treatment

Median time (months) from date of index treatment to date of next line therapy, date of death, or end of study, whichever came first, assessed up to 52 months

Median time (months) from date of index treatment to date of first use of chemotherapy, date of death, or end of study, whichever came first, assessed up to 52 months

Hospital San Carlos, Madrid

Principal Investigator

Pfizer CT.gov Call Center

This non-interventional study is designated as a Post Marketing Surveillance Study and is a commitment to Ministry of Food and Drug Safety (MFDS).

Before the approval of IBRANCE® in Korea, as a part of Risk Management Plan (RMP), which is required by MFDS, safety and efficacy information of new medication will be provided at minimum 1,000 participants administered in the setting of routine practice during the initial 9 years after the approval.

Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®

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.

This is a prospective, observational, non-interventional, multi-center study in which subjects will be administered as part of routine practice at Korean health care centers by accredited physicians.

Pfizer

Trastuzumab

Pertuzumab

Hormones

Anastrozole

Hormone Antagonists

Antineoplastic Agents, Immunological

Antineoplastic Agents, Hormonal

Aromatase Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Women and men with HR-positive, HER2-positive Metastatic Breast Cancer on trial of anastrozole, palbociclib, trastuzumab and pertuzumab

Dose I: 100 mg orally daily, day 1 to day 21, then 7 days off in a 28 day cycle (Phase 1 only) Dose II: 125 mg orally daily, day 1 to day 21, then 7 days off in a 28 day cycle

8 mg/kg IV initial loading dose, followed by 6 mg/kg IV every 21 days

840 mg IV followed by a maintenance dose of 420 mg IV every 21 days

Amy Tiersten, MD

This is a multicenter, phase I/II trial of anastrozole, palbociclib, trastuzumab, and pertuzumab is proposed as first-line therapy in metastatic hormone receptor-positive, HER2-positive breast cancer patients. In this phase I/II clinical trial, the researchers aim to establish the safety and efficacy of dual HER2 therapy in combination with palbociclib and anastrozole, which represents a novel and all biologic approach to the treatment of HR+, HER2+ metastatic breast cancer. Additionally, the researchers aim to examine potential biomarkers of response to palbociclib including cyclin D1, cyclin E1 and cyclin E2 expression levels, CDK 2, 4, and 6 levels, phosphorylated retinoblastoma expression and p16 levels. The researchers intend to use RNA sequencing to assess for other predictors of response in an unbiased manner to see if this correlates with inhibition of Ki-67 and phosphorylated retinoblastoma expression as well as evaluate for potential mechanisms of resistance.

Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in HR-positive, HER2-positive Metastatic Breast

A Multicenter, Phase I/II Trial of Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in HR-positive, HER2-positive Metastatic Breast Cancer

Data collected during the course of this clinical trial will primarily be shared with other investigators and University staff, the IRB, FDA, and other reporting agencies, and/or transferred to other collaborators. Prior to transfer, the data collected must comply with, and must be limited by, the MSH's guidelines for Protecting the Rights and Privacy of Human Subjects.

The dose-limiting toxicity (DLT) for palbociclib when administered in combination with anastrozole, trastuzumab and pertuzumab. A DLT will be defined as:

* Grade 3 or 4 non-hematologic toxicity
* Grade 3 neutropenia lasting greater than 21 days
* Grade 3 or 4 neutropenia with neutropenic fever or
* Grade 4 hematologic toxicity events experienced within the first 4 weeks (1 cycle) of study treatment. These will be assessed via the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI's CTCAE) v4.0 toxicity criteria.

The maximum tolerated dose (MTD) for palbociclib when administered in combination with anastrozole, trastuzumab and pertuzumab. If \> 33 % of patients experience a dose limiting toxicity (DLT) at any dose level, the dose level below that level will be considered the MTD. Or if the highest level has been reached and ≤ 33% of patients have experienced dose limiting toxicity (DLT), that will be considered the MTD.

CBR will be measured by the percentage of patients whose cancer shrinks or remains stable over the duration of the study. This will be measured as the sum of complete response, partial response, and stable disease for greater than or equal to 6 months.

The time from the start of treatment until confirmed disease progression or death from any cause, whichever occurs first.

incidence of adverse events as graded by the NCI CTCAE v4.0

Herbert Irving Comprehensive Cancer Center

Weill Medical College of Cornell University

NYU Langone Health

Icahn School of Medicine at Mount Sinai

Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

Prostatic Neoplasms

Hypersensitivity

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Reproductive Control Agents

Androgens

Leuprolide

Goserelin

Bicalutamide

Androgen Antagonists

Nonsteroidal Anti-Androgens

Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).

Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).

Zoladex

Lupron Depot

Maha Hussain, MD, FACP, FASCO

This study will look at the effect of adding the drug Palbociclib to CAD (Combined Androgen Deprivation) therapy in patients with RB (Retinoblastoma Protein) positive hormone sensitive prostate cancer.

The investigators hypothesize that the addition of Palbociclib to initial ADT (Androgen Deprivation Therapy) in patients with newly metastatic RB-positive prostate cancer may significantly increase the efficacy of ADT.

Patients will undergo exams, tests, and procedures to determine if they are eligible to participate. Subjects will be randomized to one of two groups. Patients randomized to Arm 1 - Patients will receive the LHRH agonist every 3 months. Patients will also take 50 mg. of bicalutamide by mouth every day. Bicalutamide comes in tablet form. This arm is broken down into periods of time called cycles, starting with cycle 1 then cycle 2, and so on.Each cycle is 28 days long. If randomized to Arm 2 - Patients will receive the LHRH agonist every 3 months. Patients will also take 50 mg. of bicalutamide by mouth every day. Patients will also take 125 mg. of Ibrance® daily for 21 days, and then will stop taking Ibrance® for 7 days. Patients will then begin taking Ibrance® again after 7 days off. Patients will keep repeating this cycle every 28 days. When the patient starts the first 28 day cycle that will be cycle 1, then cycle 2, and so on. During each cycle the patient will come in for routine and research tests and procedures for patient safety, to see how patients are doing, and for research purposes. The researchers will ask patients to complete a drug diary to track bicalutamide and Ibrance® administration. The total time of study participation depends on how a patient responds to the study medications. Patients may be on the study for a short period of time, such as a week, or for a longer period of time, such as a few years. Patients may continue on study treatment until one of the following: cancer progresses (gets worse); another illness or condition develops that prevents study participation; unacceptable side effects occur; drug is delayed more than 4 weeks; patient withdraws consent; the study doctor thinks the patient should stop; the patient does not follow researcher's instructions; the study is cancelled.

A Phase II Study of Androgen Deprivation Therapy With or Without Palbociclib in RB-Positive Metastatic Prostate Cancer

A Randomized Phase II Study of Androgen Deprivation Therapy With or Without Palbociclib in RB-Positive Metastatic Hormone-Sensitive Prostate Cancer

The primary analysis will be assessment of the proportion of patients who achieve a (Prostate-specific antigen) PSA \< 4ng/mL after seven months of protocol treatment in each arm.

Grade \>=3 adverse events that are possibly, probably or definitely related to study treatment, reported by number of participants affected in each arm

Duration of therapy will be reported to describe tolerability within each arm.

12-month biochemical progression-free survival rate will begin from treatment start until the event of biochemical (PSA) progression or death, whichever occurs first. Described by arm using Kaplan-Meier methods.

12-month clinical progression-free survival rate will begin from treatment start until the event of biochemical (PSA) progression or death, whichever occurs first. Described by arm using Kaplan-Meier methods.

Dose modifications will be reported to describe tolerability for arm 2 only (Ibrance®)

Treatment delays will be reported to describe tolerability within each arm.

University of Utah

Vanderbilt-Ingram Cancer Center

Johns Hopkins University

Thomas Jefferson University

Washington University School of Medicine

Northwestern University

City of Hope Comprehensive Cancer Center

University of Michigan Rogel Cancer Center

ADT Alone

ADT + Ibrance®

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

62 out of 72 patients enrolled had adequate tissue for RB assessment and retained RB expression. (60 patients initiated treatment.)

Phillip Palmbos, M.D., Ph.D.

With 20 patients treated with ADT and 40 treated with ADT + palbociclib there is a 64.2% power to detect a 20% difference in proportions with a one-sided type I error of 0.10 using the mid p-value method of the Fisher's exact test.

72 patients were enrolled to the trial. Seven patients did not have adequate tissue for testing retinoblastoma status. Two patients tested negative for retinoblastoma and one patient was found to have small cell metastasis and not adenocarcinoma. 62 patients were randomized. 60 randomized patients initiated therapy on trial.

Number of Patients Who Achieve a PSA ≤ 4ng/mL After Seven Months of Protocol Treatment in Each Arm

Number of Participants With Grade >=3 Adverse Events That Are Possibly, Probably or Definitely Related to Study Treatment

Duration of Therapy

Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).

Bicalutamide

Zoladex

Lupron Depot

Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).

Ibrance

Bicalutamide

Zoladex

Lupron Depot

Proportion of Patients Who Achieve Undetectable PSA (<0.2ng/mL)

12-month

26-month (time of last event in Arm 1)

43-month (time of last event in Arm 2)

Biochemical Progression-free Survival Rate

22-month (time of last event in Arm 1)

32-month (time of last event in Arm 2)

Clinical Progression-free Survival Rate

No Dose Reduction (Palbociclib 125mg/day)

1 Dose Reduction, to Palbociclib 100mg/day

2 Dose Reductions, to Palbociclib 75mg/day

Frequency of Dose Modification

No Treatment delay of Bicalutamide

Treatment Delay of Bicalutamide

No Treatment Delay of Palbociclib

Treatment Delay of Palbociclib

Frequency of Treatment Delay

Overall Study

Rare Diseases

Carcinoma

Genital Neoplasms, Female

Cystadenocarcinoma, Serous

Cystadenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Neoplasms, Cystic, Mucinous, and Serous

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Fallopian Tube Cancer

Adenocarcinoma of the Appendix

Fulvestrant

Neoadjuvant Treatment (Cycles 1-4): Fulvestrant 500 mg injection in buttocks on Days 1 and 15 of Cycle 1 and Day 1 of Cycles 2-4.

Adjuvant Treatment (Cycles 5 and beyond): Fulvestrant 500 mg injection in buttocks on Day 1 of each cycle.

Study cycle is 28 days.

Neoadjuvant Treatment (Cycles 1-4): Abemaciclib 150 mg by mouth On Days 1-28 of each cycle.

Adjuvant Treatment (Cycles 5 and beyond): On Days 1-28 of each cycle, you will take Abemaciclib 150 mg by mouth on Days 1-28 of each cycle.

Study cycle is 28 days.

Abemaciclib

Amir A. Jazaeri, MD

The goal of this clinical research study is to learn if fulvestrant and abemaciclib can help to control low-grade serous ovarian cancer. The safety of this drug combination will also be studied.

This is an investigational study. Fulvestrant and abemaciclib are both FDA approved and commercially available for the treatment of several types of cancer. Their use in patients with low-grade serous ovarian cancer is investigational. The study doctor can explain how the study drugs are designed to work.

Up to 15 participants will be enrolled in this study. All will take part at MD Anderson.

Study Drug Administration

Every study cycle will be 28 days. You will receive treatment in 2 periods: Neoadjuvant Treatment (before surgery) and Adjuvant Treatment (after surgery).

If you are premenopausal or perimenopausal, you will receive goserelin as an injection under the skin every 12 weeks. The study doctor will tell you if you will have these injections.

Neoadjuvant Treatment (Cycles 1-4) There are 4 cycles in the neoadjuvant treatment period. On Days 1 and 15 of Cycle 1 and Day 1 of Cycles 2-4, you will receive fulvestrant as an injection in your buttocks. On Days 1- 28 of each cycle, you will take abemaciclib tablets 2 times every day by mouth at about the same time each day, preferably with food.

Abemaciclib should be swallowed whole; not chewed. If a tablet is broken, cracked, or otherwise not whole, do not take it.

Surgery After 4 cycles of neoadjuvant treatment, you will have your scheduled surgery as part of your standard care. You will sign a separate consent for this surgery describing the procedure and its risks in more detail.

Adjuvant Treatment (Cycles 5 and beyond) After you have recovered from surgery (about 3-6 weeks later), you will begin receiving fulvestrant and abemaciclib. On Day 1 of each cycle, you will receive fulvestrant as an injection in your buttocks. On Days 1- 28 of each cycle, you will take abemaciclib tablets 2 times every day by mouth.

You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.

Length of Study You will receive the study drug(s) for as long as the study doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation in this study will be over after the 30-day follow-up phone call (described below).

Study Visits

On Day 1 of each cycle:

You will have a physical exam. If the study doctor thinks it is needed, you will also have a pelvic exam.

Blood (about 4 tablespoons) will be drawn for routine, tumor marker, and biomarker tests.

Urine will be collected for routine tests. If you can become pregnant, part of this blood sample will be used for a pregnancy test.

On Day 15 of Cycle 1, you will have a physical exam.

On Day 1 of odd-numbered cycles after Cycle 1 (Cycles 3, 5, 7, and so on), you will have an MRI or CT scan.

At your visit before the surgery, you will have a CT scan or MRI to check the status of the disease.

During surgery, some of the tissue removed will be used to compare to tissue collected from you before you received chemotherapy so researchers can learn if the study drugs had any affect on the disease. This sample will be stored at MD Anderson for an unlimited amount of time for testing related to this study.

End-of-Treatment Visit

After the last dose of study drug(s):

You will have a physical exam. Blood (about 1-2 tablespoons) will be drawn for routine, tumor marker, and biomarker tests.

You will have an MRI or CT scan to check the status of the disease.

Follow-Up About 30 days after the last dose of study drugs, the study staff will call you and ask how you are doing. This call should last about 5 minutes.

Fulvestrant Plus Abemaciclib in Women With Advanced Low Grade Serous Carcinoma

A Pilot Phase II Study of Neoadjuvant Fulvestrant Plus Abemaciclib in Women With Advanced Low Grade Serous Carcinoma

We are pending discussions with Eli Lilly and AstraZeneca regarding the level and quantity of data that may be shared. Discussions will also include potential modifications of the contract to allow for data sharing.

Clinical benefit rate determined by partial response (PR), complete response (CR), and stable disease (SD) associated with 4 cycles of neoadjuvant abemaciclib plus fulvestrant in patients with Low Grade Serous Carcinoma (LGSC). CBR assessed using RECIST 1.1.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Observational Analysis of Palbociclib Treatment in Patients With First Line Therapy for Locally Advanced and/or Metastatic Breast Cancer	NCT04874025	Breast Cancer	Ibrance	18 Years -	Hospital San Carlos, Madrid
Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®	NCT03445637	Breast Neoplasm		18 Years -	Pfizer
Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in HR-positive, HER2-positive Metastatic Breast	NCT03304080	Breast Neoplasm... Breast Diseases	Anastrozole Palbociclib Trastuzumab Pertuzumab	18 Years -	Icahn School of Medicine at Mount Sinai
A Phase II Study of Androgen Deprivation Therapy With or Without Palbociclib in RB-Positive Metastatic Prostate Cancer	NCT02059213	Prostate Cancer	Ibrance Bicalutamide Zoladex Lupron Depot	18 Years -	University of Michigan Rogel Cancer Center
Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in HR-positive, HER2-positive Metastatic Breast	NCT03304080	Breast Neoplasm... Breast Diseases	Anastrozole Palbociclib Trastuzumab Pertuzumab	18 Years -	Icahn School of Medicine at Mount Sinai
Fulvestrant Plus Abemaciclib in Women With Advanced Low Grade Serous Carcinoma	NCT03531645	Malignant Neopl...	Fulvestrant Abemaciclib	18 Years -	M.D. Anderson Cancer Center
Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®	NCT03445637	Breast Neoplasm		18 Years -	Pfizer
A Phase II Study of Androgen Deprivation Therapy With or Without Palbociclib in RB-Positive Metastatic Prostate Cancer	NCT02059213	Prostate Cancer	Ibrance Bicalutamide Zoladex Lupron Depot	18 Years -	University of Michigan Rogel Cancer Center
Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in HR-positive, HER2-positive Metastatic Breast	NCT03304080	Breast Neoplasm... Breast Diseases	Anastrozole Palbociclib Trastuzumab Pertuzumab	18 Years -	Icahn School of Medicine at Mount Sinai

Spots Global Cancer Trial Database for ibrance

Every month we try and update this database with for ibrance cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ibrance

Every month we try and update this database with for ibrance cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ibrance cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.