Palbociclib for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Nebraska, Lincoln, NE
Breast Cancer+4 More
Palbociclib - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This study is evaluating whether a new dosing schedule of palbociclib is better tolerated than the current dosing schedule.

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Eligible Conditions

  • Breast Cancer
  • Malignant Tumor of Breast
  • Breast Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Breast Cancer

Study Objectives

This trial is evaluating whether Palbociclib will improve 8 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of Through the 30 day follow-up (estimated to be 25 months).

1 year
Progression-free Survival (PFS)
Month 25
Rate of Grade 3 or Higher Neutropenia
Month 25
Adverse Event Profile of Palbociclib
Month 24
Rate of Palbociclib Discontinuation
Rate of Palbociclib Dose Interruption
Rate of Palbociclib Dose Reduction
Month 24
Clinical Benefit Rate (Complete Response + Partial Response + Stable Disease) for at Least 6 Months)
Overall Response Rate (Complete Response + Partial Response)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Breast Cancer

Trial Design

1 Treatment Group

Palbociclib + letrozole or + fulvestrant
1 of 1
Experimental Treatment

This trial requires 55 total participants across 1 different treatment group

This trial involves a single treatment. Palbociclib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Palbociclib + letrozole or + fulvestrantPalbociclib should be taken by mouth with food on a 5 days on/2 days off schedule (meaning: on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle). Patients who are receiving letrozole will take it daily by mouth, every day of each 28-day cycle. Patients who are receiving fulvestrant will receive it as two intramuscular injections (one into each buttock) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter. Goserelin is given as a subcutaneous injection every 28 days. It is preferred to be given on Day 1 of each cycle, but it may be administered on any day of the treatment cycle to accommodate its specific Q28-day cycle. It will be given to pre- or peri-menopausal women only. Optional research biopsy at baseline and progression Blood for research at baseline, cycle 1 day 15, cycle 2 day 1, every 2-3 months (to coincide with imaging studies), and time of progression
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
FDA approved
Letrozole
FDA approved
Palbociclib
FDA approved
Goserelin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Closest Location

University of Nebraska - Lincoln, NE

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The presence of a measurable or non-measurable disease by the RECIST 1.1 criteria. show original
Patients who have had any prior systemic therapies in the metastatic setting are not eligible show original
is defined as ALCO An absolute neutrophil count (ANC) of ≥ 1,500/mcl is defined as ALCO. show original
In most cases, total bilirubin levels will be below the institutional upper limit of normal, or 3.0 times the institutional upper limit of normal, in patients with Gilbert's syndrome show original
AST(SGOT)/ALT(SGPT) should not exceed 1.5 times the upper limit of normal (up to 5 times the upper limit of normal in patients with liver disease), unless there is a compelling clinical indication. show original
Patients who have breast cancer that is estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) and HER2-negative, and who are considered candidates for the drug palbociclib in combination with either letrozole or fulvestrant, as determined by their doctor. show original
Patients who were started on endocrine therapy as their first or second line systemic therapy in the metastatic setting and did not have clinical progression prior to the initiation of the study drug therapy are allowed to enroll on the study as their first or second line therapy, respectively. show original
This means that the person has a relatively good performance status, with only minor problems with activities of daily living. show original
Platelets ≥ 100,000/mcl
At least 18 years of age is required. show original

Patient Q&A Section

How many people get cancer a year in the United States?

"About 3.3 million people in the United States will be diagnosed with cancer in 2012. While this is a significant decrease from 2009 (13,000 cases), there has been an increase in some types of new cancer diagnoses. These include the second leading cause of childhood cancer related deaths and the second leading cause of cancer deaths in older Americans. These data can inform national initiatives regarding the need for increased surveillance, early detection, and optimal treatment of cancers." - Anonymous Online Contributor

Unverified Answer

What is cancer?

"Cancer is the abnormal cell growth in an organ that can spread or to other organs or tissues of the body. This disease affects almost half a billion people. The 5-year survival rate for many tumour types, including [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) and prostate cancer, is less than 10%. A large number of patients are diagnosed with cancer only when the disease has spread to other parts of the body. While most people with cancer receive standard treatment, not all will die within 5 years of diagnosis. For all cancer patients more information is needed on how their condition will respond to therapy." - Anonymous Online Contributor

Unverified Answer

Can cancer be cured?

"Cancer has yet to be successfully cured, and future work should focus on understanding the mechanisms of growth and metastasis. More broadly, a cure for cancer is a realistic goal for millions of people around the world." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cancer?

"This article shows the many common treatments that are used for cancer. It also highlights the importance of selecting treatments based on each individual patient's requirements." - Anonymous Online Contributor

Unverified Answer

What causes cancer?

"Cancer occurs because of random errors within cells that make them cancer cells. Some cancer genes will hopefully be identified over the next 5 years, or later. The reasons for some common cancers that affect the majority of people are currently not known. Cancer is often a result of multiple genes, environmental exposures and a combination of several risk factors. When a group of people have a higher risk of cancer, this group can be tested for increased numbers of cancer genes to seek possible explanations. Genetic and environmental factors are considered to be part of the tumor suppressor genes. The human genome has been sequenced, but genes that might be involved with cancer await identification." - Anonymous Online Contributor

Unverified Answer

What are the signs of cancer?

"This investigation did show many new symptoms and signs related to cancer. However, such signs are rare, mainly those related to the cancer site and its spread. Signs of cancer that are more common include loss of control of bowel, bladder, or sexual function; loss of sensation; weakness; and fatigue; and" - Anonymous Online Contributor

Unverified Answer

Is palbociclib safe for people?

"The frequency of adverse events was similar to that reported in clinical trials that used this agent as a single agent. There was no evidence of relevant interaction with concomitant palbociclib with CYP P450 3A4 or P-glycoprotein substrates or inverse agonists. It is unlikely that a major clinical drug interaction occurred, and it is therefore safe to use concomitant palbociclib with these medications concurrently." - Anonymous Online Contributor

Unverified Answer

Is palbociclib typically used in combination with any other treatments?

"Many combination treatments exist for metastatic breast cancer, including palbociclib plus docetaxel, palbociclib plus fluorouracil, palbociclib plus epirubicin+cyclophosphamide, palbociclib plus epirubicin+cyclophosphamide+pemetrexed, docetaxel + trastuzumab, docetaxel, docetaxel + trastuzumab, and docetaxel, and fluorouracil, and palbociclib." - Anonymous Online Contributor

Unverified Answer

Does cancer run in families?

"Data from a recent study of this study confirm the family risk factor concept for breast cancer. However, we have identified only one candidate gene as a possible predisposing locus for breast cancer." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for cancer?

"The survival rates in the past for cancer varied largely based on the type of cancer. The most common types of cancer had a high survival rates, while others did not. Many of the cancer patients die before they become cancer patients; one reason can be the cancer cells are resistant to drugs. Also, many of the patients with metastatic cancer have their survival rate reduced compared to the one without the metastasis. They are mostly seen after the metastatic cancer cells have spread and taken a life for the person. This process is known as the cancer progression." - Anonymous Online Contributor

Unverified Answer

How quickly does cancer spread?

"Cancer can spread to distant sites in both time and space, both within the human body and in the surrounding environment. The rate of these metastatic events may be strongly influenced by biological and physical factors." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving palbociclib?

"In summary, PD-1 inhibitors in general, and PD-1 drugs in particular, have only recently entered the clinical arena; prior to this, clinical trials of them were very few, especially of newer agents where they had not been thoroughly investigated. The recent clinical findings are in accord with what we currently have found in literature: that a variety of cancers, including breast as well as other very common cancers in elderly people may be affected by these drugs, and that trials of this class of drugs are very likely to occur. I think this is an important question that needs to be researched." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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