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New treatment option for Breast Cancer
Official title Personalized Antiemetic Regimen According to Patients' Pharmacogenetic Profile
ClinicalTrials.gov ID: NCT07455955
What this study is testing
What is Standard antiemetic regimen or Olanzapine antiemetic regimen?
Standard antiemetic regimen or Olanzapine antiemetic regimen is an investigational medicine, given as an once-daily, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The objectives of this study are to determine if pharmacogenetic (PG) analysis of an individual enable optimal selection of antiemetic regimen for patients undergoing the first cycle of AC (Adriamycin + Cyclophosphamide) or FEC (Fluorouracil + Epirubicin + Cyclophosphamide) chemotherapy. It also aims to compare the quality of life of patients in the first cycle of AC / FEC chemotherapy with and without PG analysis.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 74, women only
You may be able to join if
- Chinese patient, female \>/=18 and \< 75 years of age.
- Patient is diagnosed with early breast cancer.
- Patient is naïve to emetogenic chemotherapy moderately or highly emetogenicity.
- Patient is scheduled to receive her first course of neoadjuvant/adjuvant chemotherapy for breast cancer follows: AC: Intravenous (IV) Adriamycin 60...
- Patient has a predicted life expectancy of 4 months.
You likely can't join if
- Patient with advanced breast cancer.
- Patient receiving cisplatin or any other chemotherapy of higher emetogenic potential, except for cyclophosphamide and doxorubicin in the regimens...
- Patients who are scheduled to receive concurrent radiation as part of their chemotherapy regimen for their malignancy
- Patients who experience any vomiting or grade 2-3 nausea per Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v 4.03) in the 24...
- Patient has a history of treatment with moderately to highly emetogenic chemotherapy.
- Patient has an active infection (e.g., pneumonia, systemic fungal infection) or any uncontrolled disease (e.g., diabetes mellitus, hypertension)...
See the full eligibility criteria
- Chinese patient, female \>/=18 and \< 75 years of age.
- Patient is diagnosed with early breast cancer.
- Patient is naïve to emetogenic chemotherapy moderately or highly emetogenicity.
- Patient is scheduled to receive her first course of neoadjuvant/adjuvant chemotherapy for breast cancer follows: AC: Intravenous (IV) Adriamycin 60 mg/m\^2 + Cyclophosphamide 600 mg/m\^2, given as 14-day cycle or 21-day...
- Patient has a predicted life expectancy of 4 months.
- Patient has ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-1.
- Premenopausal female patients must not be pregnant (documented negative urine pregnancy test).
- Patient is able to read, understand and complete study questionnaires and diary, including questions requiring a visual analog scale (VAS) response.
- Patient understands the procedures and agrees to participate in the study by giving written informed consent.
- Patient with advanced breast cancer.
- Patient receiving cisplatin or any other chemotherapy of higher emetogenic potential, except for cyclophosphamide and doxorubicin in the regimens described above.
- Patients who are scheduled to receive concurrent radiation as part of their chemotherapy regimen for their malignancy
- Patients who experience any vomiting or grade 2-3 nausea per Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v 4.03) in the 24 hours before Day 1 of chemotherapy
- Patient has a history of treatment with moderately to highly emetogenic chemotherapy.
- Patient has an active infection (e.g., pneumonia, systemic fungal infection) or any uncontrolled disease (e.g., diabetes mellitus, hypertension) which, in the opinion of the investigator, might confound the results of...
- Patient with history of glaucoma, dementia, seizures, Parkinson's disease, Neuroleptic Malignant Syndrome (NMS), thromboembolic events.
- Patient currently uses any illicit drugs, including marijuana, or has current evidence of alcohol abuse as determined by the investigator.
- Patient is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry.
- Patients who are regular alcohol drinker or smoker
- Patient has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose unwarranted risk.
- Patient has a history of hypersensitivity to aprepitant, ondansetron or dexamethasone.
- Patients who have phenylketonuria and abnormal uric acid.
- Any investigational drugs taken within 4 weeks prior to Day 1 of cycle 1, and/or is scheduled to receive any investigational drug during the study.
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.