Olaparib for BRCA 1 Gene Mutation

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Research Site, Shanghai, China
BRCA 1 Gene Mutation+3 More
Olaparib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new drug called olaparib can improve the survival of people with breast cancer.

See full description

Eligible Conditions

  • BRCA 1 Gene Mutation
  • Breast Cancer Metastatic
  • brca2 Gene Mutation

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for BRCA 1 Gene Mutation

Study Objectives

This trial is evaluating whether Olaparib will improve 1 primary outcome, 7 secondary outcomes, and 4 other outcomes in patients with BRCA 1 Gene Mutation. Measurement will happen over the course of Second progression status reviewed every 8 weeks following the first objective radiological progression as per investigator assessment. Assessed up to a maximum of 30 months..

Month 30
Adjusted Mean Change in Global Health Status/Quality of Life (QoL) Score From the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30)
Month 30
Objective Response Rate (ORR) Using Blinded Independent Central Review (BICR) Data Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)
Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)
Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) in Patients Confirmed as Myriad CDx gBRCAm
Month 30
Time to Second Progression or Death (PFS2)
Month 64
Time to First Subsequent Cancer Therapy or Death (TFST) at Extended OS
Time to Second Subsequent Cancer Therapy or Death (TSST) at Extended OS
Month 30
Time to First Subsequent Cancer Therapy or Death (TFST)
Time to Second Subsequent Cancer Therapy or Death (TSST)
Month 64
Overall Survival (OS) at Extended OS
Month 30
Overall Survival (OS)
Month 40
Overall Survival (OS) at Final OS

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for BRCA 1 Gene Mutation

Side Effects for

Unassigned (Not BRCAm, Not HRRm^)
Vomiting
50%
Neutrophil count decreased
50%
Fatigue
50%
Foot fracture
50%
Small intestinal obstruction
50%
Taste disorder
50%
Anaemia
50%
Gastrooesophageal reflux disease
50%
Irritability
50%
Personality change
50%
Deep vein thrombosis
0%
Nausea
0%
Transient ischaemic attack
0%
Pyrexia
0%
Arthralgia
0%
Platelet count decreased
0%
Vertigo
0%
Muscle spasms
0%
Thrombocytopenia
0%
Dysarthria
0%
Dyspepsia
0%
Headache
0%
Blood creatinine increased
0%
Sepsis
0%
Back pain
0%
Pain in extremity
0%
Myocardial infarction
0%
Sudden death
0%
Glomerular filtration rate decreased
0%
Atrial fibrillation
0%
Procedural pain
0%
Urinary tract infection
0%
Acute myeloid leukaemia
0%
Abdominal distension
0%
Abdominal pain lower
0%
Oedema peripheral
0%
Influenza
0%
Alanine aminotransferase increased
0%
White blood cell count decreased
0%
Anxiety
0%
Neutropenia
0%
Abdominal pain
0%
Mesenteric vein thrombosis
0%
Asthenia
0%
Nasopharyngitis
0%
Alopecia
0%
Angina unstable
0%
Musculoskeletal pain
0%
Abdominal pain upper
0%
Leukopenia
0%
Constipation
0%
Papillary thyroid cancer
0%
Burkitt's lymphoma
0%
Dyspnoea
0%
Decreased appetite
0%
Upper respiratory tract infection
0%
Influenza like illness
0%
Hypomagnesaemia
0%
Myalgia
0%
Dizziness
0%
Pruritus
0%
Cough
0%
Rash
0%
Pulmonary embolism
0%
Pleural effusion
0%
Oral candidiasis
0%
Dysgeusia
0%
Oropharyngeal pain
0%
Depression
0%
Abdominal hernia
0%
Diarrhoea
0%
Mucosal inflammation
0%
Respiratory tract infection
0%
Colonic abscess
0%
Contrast media allergy
0%
Gastroenteritis viral
0%
Lower respiratory tract infection
0%
Femoral neck fracture
0%
Insomnia
0%
Peripheral swelling
0%
This histogram enumerates side effects from a completed 2021 Phase 4 trial (NCT02476968) in the Unassigned (Not BRCAm, Not HRRm^) ARM group. Side effects include: Vomiting with 50%, Neutrophil count decreased with 50%, Fatigue with 50%, Foot fracture with 50%, Small intestinal obstruction with 50%.

Trial Design

2 Treatment Groups

Physician's choice chemotherapy
1 of 2
Olaparib
1 of 2
Active Control
Experimental Treatment

This trial requires 302 total participants across 2 different treatment groups

This trial involves 2 different treatments. Olaparib 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 3 and have had some early promising results.

Olaparib
Drug
Olaparib tablet 300mg bd po
Physician's choice chemotherapy
Drug
Capecitabine 2500 mg/m2 d1-14 q 21, or Vinorelbine 30 mg/m2 d1,8 q 21, or Eribulin 1.4 mg/m2 d1,8 q 21
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation until sep 2017 (final os dco), then every 3 months. assessed up to a maximum of 64 months.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation until sep 2017 (final os dco), then every 3 months. assessed up to a maximum of 64 months. for reporting.

Closest Location

Research Site - Jacksonville, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
A mutation in either BRCA1 or BRCA2 that is predicted to be harmful or that is suspected to be harmful. show original
ER/PR breast cancer positive patients must have received at least one endocrine therapy (adjuvant or metastatic), and must have progressed on that therapy show original
A diagnosis of breast cancer that has spread to other parts of the body. show original
Previously, the person had been treated with an anthracycline and a taxane either as adjuvant therapy or for metastatic cancer. show original
The old policy allowed platinum treatments as long as there was no progression of the breast cancer during treatment or if the treatment was given in an adjuvant/neoadjuvant setting at least 12 months after the last dose. show original
ECOG performance status 0-1.
This patient has adequate bone marrow, kidney, and liver function. show original

Patient Q&A Section

What are common treatments for breast cancer?

"The most common treatment for breast cancer is lumpectomy; however, mastectomy is the most common removal procedure for the disease. In addition, chemotherapy is often used as an adjuvant treatment for both lumpectomy and mastectomy procedures." - Anonymous Online Contributor

Unverified Answer

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

"A total of 1,814,300 men and 1,531,700 women in the US were diagnosed with breast cancer during the year 2010. Approximately 0.83 percent men and 0.76 percent women were diagnosed with breast cancer each month in the year 2010. The average age when breast cancer was diagnosed in men and women was 54 years. Breast cancer is a disease that can affect males and females equally.  In 2000 approximately two-thirds of US men and one-third of US women had screening mammograms within the 12 months following breast cancer diagnosis. Screening reduces the rate that new cases of breast cancer occur by 40%." - Anonymous Online Contributor

Unverified Answer

What causes breast cancer?

"Breast cancer susceptibility is conferred mostly on women's sex. Some genes may be involved in determining risk, but several other factors such as diet, body weight, hormones, and infectious agents may also affect breast cancer risk.\n" - Anonymous Online Contributor

Unverified Answer

What is breast cancer?

"Breast cancer is a cancer that begins in the tissues of the breasts and progressively invades nearby tissues. Breast cancer typically affects older women, and it is much more common in women. It also tends to run a protracted course, which is why, in the final stages of the disease, it can also affect men and children." - Anonymous Online Contributor

Unverified Answer

Can breast cancer be cured?

"Current treatment options give cure rate estimates of up to 86% but this result is highly reliant on the patient selection and response to treatment. In an era where adjuvant treatment gives cure rate estimates of up to 84%, a higher cure rate of up to 85% would be highly probable with appropriate therapies." - Anonymous Online Contributor

Unverified Answer

What are the signs of breast cancer?

"The symptoms of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) can vary greatly among women, so some symptoms, such as a lump or discharge, can be inconsistent. For example, a lump on the right breast or nipple, which can be painful to touch, might be an early sign of breast cancer, but if the symptoms seem to be inconsistent with breast cancer, it is more likely to be a nipple discharge. Some other symptoms, such as a lump in the left breast or breast area would be more likely to be symptoms of breast cancer. Breast cancer can also include skin changes or sores." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for breast cancer?

"Survival rate varies considerably between the different countries. After controlling for pathological and biological characteristics, there were no significant differences in overall and breast cancer specific survival rates between Caucasian breast cancer patients from Norway, Canada, and the United States. Nevertheless, American patients had lower overall survival, probably in view of their higher nodal and distant metastases rate and age at diagnosis." - Anonymous Online Contributor

Unverified Answer

Is olaparib typically used in combination with any other treatments?

"In the absence of evidence to the contrary, we consider single agent PARP-inhibitors (e.g., AZD-8055) an effective drug to be used in any treatment regimen. However, there is no justification for using olaparib in the absence of other treatments, such as cisplatin." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating breast cancer?

"There have been major advances in understanding the molecular basis of cancer, which has led to increased understanding of the role of specific genes in the tumorigenic process, and new anti-tumor approaches that are currently evaluated in clinical trials. These have created significant opportunities for developing rational pharmaceutical agents for breast cancer. In the future, we anticipate that cancer gene therapy using siRNA that targets aberrant cancer genes will be more accurate to manage breast cancer and its associated risk of metastatic disease." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in olaparib for therapeutic use?

"Olaparib has been studied for several weeks in patients with advanced breast cancer. The FDA and EMA now both require New Drug Applications (NDA) for olaparib. The NDA requires an additional 6 months of preclinical data to test safety and efficacy of olaparib. The EMA also requires additional preclinical data for proof of concept of oParib to support the submission of a Marketing Authorization Application (MAA), and the EMA will provide a similar recommendation as the FDA. This may mean that the market for olaparib will be slower to commence in the EU than in the USA." - Anonymous Online Contributor

Unverified Answer

What does olaparib usually treat?

"It is imperative to note that olaparib does not treat [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer). The compound does not affect the development of cancer by itself. Rather, it acts by slowing down the spread of cancer cells. For this combination to be effective it may also be necessary to take other drugs such as cetuximab in conjunction with olaparib for a longer period. The mechanism to action of olaparib seems to be very similar to that of cisplatin, a chemotherapeutic drug used to treat bladder cancer." - Anonymous Online Contributor

Unverified Answer

How does olaparib work?

"This is the first large clinical trial to demonstrate the therapeutic efficacy of olaparib. Results also support the hypothesis that PARP inhibition can improve OS even in patients with previously treated recurrence. Clin Cancer Res; 1-5. ©2015 AACR." - 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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