Ibrance

Breast, Advance Directives, Postmenopause + 3 more

Treatment

9 FDA approvals

6 Active Studies for Ibrance

What is Ibrance

Palbociclib

The Generic name of this drug

Treatment Summary

Palbociclib is a medication that works by affecting the cell cycle machinery. It is a type of cyclin-dependent kinase inhibitor that was developed by Pfizer Inc to treat certain types of breast cancer. Palbociclib was originally approved by the FDA in March 2015 for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in women. The indications for Palbociclib were then expanded in 2019 to also include male patients based on evidence from clinical studies.

Ibrance

is the brand name

image of different drug pills on a surface

Ibrance Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Ibrance

Palbociclib

2015

12

Approved as Treatment by the FDA

Palbociclib, also known as Ibrance, is approved by the FDA for 9 uses including Metastatic Breast Cancer and refractory, metastatic Breast cancer .

Metastatic Breast Cancer

Used to treat Metastatic Breast Cancer in combination with Fulvestrant

refractory, metastatic Breast cancer

Used to treat refractory, metastatic Breast cancer in combination with Letrozole

Advanced Breast Cancer

Used to treat Advanced Breast Cancer in combination with Fulvestrant

Postmenopause

Used to treat Postmenopausal in combination with Fulvestrant

Metastatic Breast Cancer

Used to treat Metastatic Breast Cancer in combination with Fulvestrant

Advance Directives

Used to treat refractory, advanced Breast cancer in combination with Letrozole

prior endocrine therapy

Used to treat prior endocrine therapy in combination with Fulvestrant

Breast

Used to treat refractory, metastatic Breast cancer in combination with Letrozole

Breast

Used to treat Advanced Breast Cancer in combination with Fulvestrant

Effectiveness

How Ibrance Affects Patients

Palbociclib works by blocking cell growth and DNA replication in certain cancer cells, making them unable to reproduce and grow. This stops the cells from moving into the next stage of the cell cycle, which leads to them not being able to divide and reproduce. Studies on breast cancer cells have found that this drug is more effective in cells with high levels of a certain protein called RB1, low levels of a protein called CDKN2A, and medium levels of a protein called CCND1. In clinical trials, when taken with letrozole, palbociclib was able to increase the length of time without cancer

How Ibrance works in the body

Palbociclib is a drug that stops cancer cells from reproducing. It works by binding to an enzyme called CDK4/6, which controls the transition of cells from the G1 phase to the S phase. Palbociclib prevents this transition, thus halting the growth of cancer cells. It also stops the phosphorylation of proteins like retinoblastoma, which are involved in cell cycle progression. Palbociclib is effective against CDK4/6, but not other types of enzymes.

When to interrupt dosage

The degree of Ibrance is contingent upon the identified disorder, including Breast, Advance Directives and prior hormonal treatment. The quantity of dosage is determined by the technique of administration documented in the table below.

Condition

Dosage

Administration

Breast

125.0 mg, , 75.0 mg, 100.0 mg

, Oral, Capsule, Capsule - Oral, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral

prior endocrine therapy

125.0 mg, , 75.0 mg, 100.0 mg

, Oral, Capsule, Capsule - Oral, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral

Advance Directives

125.0 mg, , 75.0 mg, 100.0 mg

, Oral, Capsule, Capsule - Oral, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral

Postmenopause

125.0 mg, , 75.0 mg, 100.0 mg

, Oral, Capsule, Capsule - Oral, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral

Metastatic Breast Cancer

125.0 mg, , 75.0 mg, 100.0 mg

, Oral, Capsule, Capsule - Oral, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral

Breast

125.0 mg, , 75.0 mg, 100.0 mg

, Oral, Capsule, Capsule - Oral, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral

Warnings

There are 20 known major drug interactions with Ibrance.

Common Ibrance Drug Interactions

Drug Name

Risk Level

Description

9-(N-methyl-L-isoleucine)-cyclosporin A

Major

The risk or severity of adverse effects can be increased when Palbociclib is combined with 9-(N-methyl-L-isoleucine)-cyclosporin A.

Abemaciclib

Major

The serum concentration of Abemaciclib can be increased when it is combined with Palbociclib.

Acalabrutinib

Major

The metabolism of Acalabrutinib can be decreased when combined with Palbociclib.

Acteoside

Major

The risk or severity of adverse effects can be increased when Palbociclib is combined with Acteoside.

Alectinib

Major

The metabolism of Alectinib can be decreased when combined with Palbociclib.

Ibrance Toxicity & Overdose Risk

The lowest toxic dose of palbociclib taken orally is 100 mg/kg. If a person takes too much, only supportive measures can be taken. Additionally, palbociclib has been found to cause genetic damage and can harm unborn babies due to how it works. High doses of palbociclib have also been linked to an increased risk of brain tumors.

image of a doctor in a lab doing drug, clinical research

Ibrance Novel Uses: Which Conditions Have a Clinical Trial Featuring Ibrance?

At present, 94 active studies are assessing the potential of Ibrance to mitigate Postmenopausal symptoms, Breast Cancer and prior Endocrine Therapy.

Condition

Clinical Trials

Trial Phases

Metastatic Breast Cancer

1 Actively Recruiting

Phase 1, Phase 2

Breast

0 Actively Recruiting

Breast

0 Actively Recruiting

Postmenopause

5 Actively Recruiting

Phase 2, Not Applicable

Advance Directives

0 Actively Recruiting

prior endocrine therapy

0 Actively Recruiting

Ibrance Reviews: What are patients saying about Ibrance?

5

Patient Review

11/1/2016

Ibrance for Estrogen Receptor (ER)-Positive, HER2-Negative Postmenopausal Advanced Breast Cancer

Ibrance has been working well for me so far. My tumor has shrunk a little bit, and I'm hopeful that it will continue to do so. I've had some stomach issues and fatigue, but overall I feel great.

5

Patient Review

6/26/2018

Ibrance for Estrogen Receptor (ER)-Positive, HER2-Negative Postmenopausal Advanced Breast Cancer

I was diagnosed in 2015 and metastasized to both bottom vertebrae. I started on Ibrance with letrozole. I had a little joint problem in my fingers however Dr. said it was side effect of the Letrozole not the Ibrance.No side effects from Ibrance to speak of. Pet scans every six months, all have been clear. Next one up is July 18th..Dr. calls me a rockstar and I am so thankful for this drug!!!! God Bless Everyone!!!

5

Patient Review

8/7/2020

Ibrance for Estrogen Receptor (ER)-Positive, HER2-Negative Postmenopausal Advanced Breast Cancer

Letrozole/Ibrance has been a godsend. After just one day of treatment, the pain in my lower back from metastasis lessened significantly. I've now had seven cycles with no progression of bone destruction according to two scans. The only drawbacks have been loose stools and hair thinning, but these are minor compared to the relief I've experienced.

5

Patient Review

11/29/2020

Ibrance for Estrogen Receptor (ER)-Positive, HER2-Negative Postmenopausal Advanced Breast Cancer

I was diagnosed with stage 4 breast cancer that had spread to my lungs, spine, and ribs. I started treatment with Ibrance and Letrazole. The side effects were manageable (hair loss) but after 7 months my blood counts were low so I switched to a lower dose of Ibrance. After 8 months my cancer markers have gone from 117 to 65 and I feel good overall.

5

Patient Review

3/16/2019

Ibrance for malignant tumor or cancer

Ibrance has been great for me, except for the fatigue and itchy scalp. But those are manageable side effects considering the benefits I've seen.

5

Patient Review

1/15/2018

Ibrance for Estrogen Receptor (ER)-Positive, HER2-Negative Postmenopausal Advanced Breast Cancer

I've been taking this for 20 months now with zero side effects. It's really a miracle drug!

5

Patient Review

5/22/2016

Ibrance for Estrogen Receptor (ER)-Positive, HER2-Negative Postmenopausal Advanced Breast Cancer

4.3

Patient Review

7/4/2017

Ibrance for Estrogen Receptor (ER)-Positive, HER2-Negative Postmenopausal Advanced Breast Cancer

I had a really bad reaction to the Ibrance 125 mg, to the point where I had to wear gloves all the time. Once I stopped taking it, my hands started peeling. 100mg is much better, but it still makes me tired.

4

Patient Review

7/19/2016

Ibrance for Estrogen Receptor (ER)-Positive, HER2-Negative Postmenopausal Advanced Breast Cancer

3.7

Patient Review

8/23/2017

Ibrance for Hormone Receptor (HR)-Positive, HER2-Negative Advanced Breast Cancer in Woman

Fasodex has been working well for me so far. My markers are stable and I haven't experienced any negative side effects.

2.7

Patient Review

5/26/2017

Ibrance for Estrogen Receptor (ER)-Positive, HER2-Negative Postmenopausal Advanced Breast Cancer

I've been fighting stage IV metastatic breast cancer for a while now. I had six months of chemotherapy, which got rid of all signs of the disease. However, it came back two months later in a different form. I've been on this new treatment regimen of Faslodex, Lupron, and Ibrance for three months now. So far, the side effects have been manageable compared to chemo; my biggest issues are joint pain, mild mouth sores, and fatigue. I'm hoping that this treatment will be effective so that I can finally put this behind me.

2.3

Patient Review

7/17/2017

Ibrance for Hormone Receptor (HR)-Positive, HER2-Negative Advanced Breast Cancer in Woman

My Mother was prescribed Ibrance after her breast cancer metastasized into her spine in a couple spots. In June, her MRI and scans show that it has now spread throughout her spine, hip, and ribs. It seems like it hasn't helped at all and may have even contributed to additional growth.

1.3

Patient Review

7/13/2017

Ibrance for Estrogen Receptor (ER)-Positive, HER2-Negative Postmenopausal Advanced Breast Cancer

Letrozole and 125 ibrance have been really effective in treating my stage 4 cancer. The only downside is that I've lost almost all of my hair.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about ibrance

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the life expectancy on Ibrance?

"The median overall survival for women treated with Ibrance and Faslodex was 34.9 months, while the median overall survival for women treated with Faslodex alone was 28.0 months."

Answered by AI

What does Ibrance do to the body?

"IBRANCE interfere with the activity of the proteins CDK4 and CDK6, which are necessary for both healthy and cancer cells to divide. Hormonal therapy blocks or reduces the binding of hormones with hormone receptors to prevent the cells from growing and dividing."

Answered by AI

Is Ibrance like chemo?

"Bottom Line: Ibrance is not a traditional form of chemotherapy. It is an oral medication known as a targeted therapy, and is in the class of drugs known as CDK 4/6 inhibitors. It helps to slow cell growth in both cancer cells and healthy cells."

Answered by AI

What type of cancer does Ibrance treat?

"Ibrance is a cancer medication that works by inhibiting certain enzymes in the body. It is used in combination with an aromatase inhibitor, a type of hormonal therapy, to treat hormone-receptor-positive, HER2-negative breast cancer that has not been treated with hormonal therapy before. This medication is for use in postmenopausal women or men."

Answered by AI

Clinical Trials for Ibrance

Image of Don tyson Center for Agricultural Sciencers in Fayetteville, United States.

Protein and Exercise for Postmenopausal Women

Any Age
Female
Fayetteville, AR

The goal of this clinical trial is to learn if consuming a higher protein diet that includes one serving of beef each day, in combination with resistance exercise, improves wellbeing in postmenopausal women. It will also tell us about how higher protein intake changes body composition and blood values related to health. The main questions it aims to answer are: * Does higher protein intake combined with resistance training improve mood and sleep in postmenopausal women? * What other health benefits to postmenopausal women experience when the follow a higher protein diet and participate in resistance exercise? Researchers will compare three groups 1) postmenopausal women living their daily lives as usual, 2) postmenopausal women consuming a higher protein diet, and 2) postmenopausal women consuming a higher protein diet and participating in resistance training. Participants will: * Consume a higher protein diet for 16 weeks * Participate in an at-home resistance training for 16 weeks * Keep a diary of their food intake, sleep habits, and mood * Have health assessments every 4 weeks

Recruiting
Has No Placebo

Don tyson Center for Agricultural Sciencers (+1 Sites)

Jamie Baum

Image of The Buck Institute for Research on Aging in Novato, United States.

GLYLO Supplement for Postmenopausal Aging

45 - 65
Female
Novato, CA

The aim of this study is to assess the effectiveness of GLYLO, a dietary supplement, in postmenopausal women aged 45 to 65 who are overweight or obese and have elevated HbA1c levels. Specifically, the study seeks to evaluate whether GLYLO can reduce advanced glycation end products (AGEs) levels, which are harmful compounds formed when sugar attaches to proteins or fats in the body and can contribute to aging and disease. The primary outcome of the study is to determine if GLYLO reduces AGEs, enhances metabolic and hormonal health, and mitigates age-related functional decline. This study includes one screening visit and three testing visits over a 6-month period. After eligibility is confirmed, participants will be randomly assigned to one of two groups to take either GLYLO (two capsules daily) or a placebo at home for 24 weeks. Participants will provide blood samples at every visit. During the three testing visits, they will complete physical performance and cognitive function tests, provide both blood and urine samples, and fill out quality of life and 24-hour dietary intake questionnaires. The dietary intake questionnaires will be completed only twice i.e. at the baseline visit and again at the final 6-month visit.

Recruiting
Advanced

The Buck Institute for Research on Aging

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