Ribociclib for Breast Cancer

Phase-Based Estimates
1
Effectiveness
2
Safety
Novartis Investigative Site, Saint Herblain cedex, France
Breast Cancer+1 More
Ribociclib - Drug
Eligibility
18+
Female
Eligible conditions
Breast Cancer

Study Summary

This study is evaluating whether a reduced dosing regimen of ribociclib might decrease the risk of QTc prolongation without compromising the efficacy of ribociclib in combination with an NSAI in pre- and postmenopausal women with HR

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Eligible Conditions

  • Breast Cancer
  • Breast Neoplasms

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Ribociclib will improve 1 primary outcome and 8 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of Cycle 1 Day 15.

Approximately 36 months
Clinical benefit rate (CBR)
Duration of response (DOR)
Progression-free survival (PFS)
Time to response (TTR)
At least 6 months
Overall Response Rate (ORR)
Cycle 1 Day 15
Pharmacokinetics (PK) of ribociclib: AUC0 - 24h
Pharmacokinetics (PK) of ribociclib: Cmax
Pharmacokinetics (PK) of ribociclib: Tmax
Day 15
Δ QTcF at Cycle 1 Day 15 (at 2h post-dose) (Key Secondary Endpoint)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Ribociclib 600 mg
Ribociclib 400 mg

This trial requires 376 total participants across 2 different treatment groups

This trial involves 2 different treatments. Ribociclib 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.

Ribociclib 400 mgRibociclib 400 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+goserelin in premenopausal women)
Ribociclib 600 mgRibociclib 600 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+ goserelin in premenopausal women)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ribociclib
FDA approved
Goserelin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 36 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly approximately 36 months for reporting.

Closest Location

Mount Sinai School of Medicine CFTY720D2306 - New York, NY

Eligibility Criteria

This trial is for female patients aged 18 and older. You must have received 1 prior treatment for Breast Cancer or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patient has a histologically and/or cytologically confirmed diagnosis of ER-positive and/or PgR-positive breast cancer based on the most recently analyzed tissue sample, and all tested by local laboratory.
Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing and based on the most recently analyzed tissue sample.
Patient must have measurable disease, i.e., at least one measurable lesion according to RECIST version 1.1. (a lesion in a previously irradiated site may only be counted as a target lesion if there is clear evidence of progression since the irradiation).
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
QTcF interval at screening < 450 ms (QT interval using Fridericia's correction)
Patient has advanced (loco-regionally recurrent or metastatic) breast cancer not amenable to curative therapy.
Mean resting heart rate 50 to 90 bpm (determined from the ECG)
Women of childbearing potential (CBP), defined as all women physiologically capable of becoming pregnant, must have confirmed negative serum pregnancy test (for β-hCG) within 14 days prior to randomization.
Women of CBP must be willing to use highly effective methods of contraception.
Key

Patient Q&A Section

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

How quickly does breast cancer spread?

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Data from a recent study cohort, the number of locospheres increased and metastatic disease was rare. Lymph node metastasis does not preclude cure with complete breast conservation treatment.

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Can breast cancer be cured?

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In a recent study, findings suggest that in a minority of patients with early-stage breast cancer, treatment of the breast cancer plus surgery to remove the existing malignant mass can result in removal of the primary tumor and prevention of future breast cancer. However, even in patients who have a very good prognosis, treatment of the primary breast cancer alone or with postoperative chemotherapy and/or radiation therapy is necessary and can provide a survival benefit of up to 12 months.

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What is breast cancer?

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Breast cancer is a cancer that forms in the breast, and typically occurs in women over the age of 50. Women typically experience pain and lump in the breast and breast cancer can spread to other parts of the body. The cause of breast cancer is relatively unknown, but is believed to be caused by environmental factors including diet, hormones and lifestyle. There are two main types of breast cancer, the tumours in which the cells are more likely to form in clusters (known as ductular carcinoma in situ) or the more deadly tumour cells (known as invasive carcinoma). The first is usually detected early and is unlikely to spread. The second type may spread early but the disease tends to get better as it gets diagnosed early.

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What are the signs of breast cancer?

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Breast cancer signs and symptoms are often subtle and nonspecific and may include: nipple cracking, nipple redness, nipple rash, pain and swelling around both breasts, nipple discharge, abdominal enlargement and weight loss.\n

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What are common treatments for breast cancer?

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Chemotherapy is an effective treatment for [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer). It remains one of the most effective treatments available for women with node-positive early-stage breast cancer. Breast self-examination and mammography in early and mid-life are effective preventive procedures. Surgery is effective in treating most stages of breast, endocrine, and lymphatic cancers, and also improves quality of life. Breast cancer is uncommon in women over 75 years old.

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

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At the time of this study, 6,632 new cases of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) were detected in patients aged 20 and older. This was 4% of all breast, cancer cases reported to the US database during 1999 and 2000. The incidence of screening mammograms and other forms of breast cancer screening seems to have increased during this time period. This increase was especially evident at younger ages. However, for a given age, incidence tended to be more for men than for women.

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What causes breast cancer?

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Breast cancer is caused by the presence of oncogenic viruses and environmental chemicals. The latter are absorbed through the food chain and can trigger the growth of a cancerous cell that normally has no growth rate and cannot survive in the absence of such signals.

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Have there been other clinical trials involving ribociclib?

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The clinical trial data for ribociclib are not adequately reported and therefore are misleading. Further, there exist no data from a trial evaluating the effect of ribociclib in patients with low disease burden (mixed breast, and breast tumors up to 2 cm in diameter). Patients are an important part of the design and interpretation of a clinical study, and, therefore, clinical relevance is highly dependent on whether trial data are reported. A well-designed clinical trial in patients with advanced breast cancer whose disease burden is in the range of current practice is necessary to establish the effect of ribociclib on survival in patients aged younger than 50 years.

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What is the primary cause of breast cancer?

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The relative importance of the various risk factors and their interaction is not entirely clear-cut. Some environmental and genetic risk factors for breast cancer are probably more important in some geographic locations than in others. To prevent breast cancer, we must better understand the complex interrelationships among the risk factors. The current lack of data on diet, lifestyle, and genetic polymorphisms of breast cancer risk is a major deficiency; a lack of which leads to delays in assessing risk and initiating preventive measures. It should be stressed that the data on risk factors should include the types of women who have them. In developing preventive measures, the women themselves should be asked what causes them concern, and the specific risk factors should be identified.

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What does ribociclib usually treat?

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Ribociclib is most effective in treating the proliferating breast cancer cell cycle regulators. Breast cancer types with ER-negative breast cancers are most responsive to ribociclib treatment. Ribociclib can be safely administered to patients in breast cancer patients with BRCA1/2 or BRCA2 mutations when the benefit outweighs the risk of long-term toxicity. Ribociclib also has a broad therapeutic opportunity in other cell cycle pathways, such as EGFR targeting as a post-synthetic alkylating agent in EGFR mutant non-small cell lung cancer.

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Has ribociclib proven to be more effective than a placebo?

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Ribociclib is more effective than a placebo for patients with metastatic hormone receptor-positive breast cancer in pre- or neoadjuvant setting regardless of time since diagnosis.

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What are the chances of developing breast cancer?

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Results from a recent clinical trial does not support the notion that a predisposition to breast cancer exists. Although it has sometimes been suggested that a woman's chance of developing breast cancer increases with age, this study shows that there is little relationship between age of onset and the risk of developing breast cancer.

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Get access to this novel treatment for Breast Cancer by sharing your contact details with the study coordinator.