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New treatment option for Advanced Breast Carcinoma
Official title Olaparib With Cediranib or AZD6738 for the Treatment of Advanced or Metastatic Germline BRCA Mutated Breast Cancer
ClinicalTrials.gov ID: NCT04090567
What this study is testing
What is Cediranib?
Cediranib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for advanced breast carcinoma.
Also referred to as AZD2171.
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
- This phase II trial studies how well olaparib with cediranib or AZD6738 works in treating patients with germline BRCA mutated breast cancer that has spread to other places in the body (advanced or metastatic). Olaparib, cediranib, and AZD6738 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
- 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 and older, women only
You may be able to join if
- Provision of informed consent prior to any study specific procedures
- Women age greater than 18 years with advanced/metastatic HER2 negative, BRCA germline positive breast cancer. Estrogen receptor positive (ER+)...
- Eligible patients must agree to a mandatory fresh biopsy (excluding bone) at screening. In addition, if available, an archival tissue sample will...
- Patients must have normal organ and bone marrow function measured within 28 days (baseline screening) as defined below:
- Hemoglobin (Hgb) \>/= 10.0 g/dL with no blood transfusion in the past 28 days prior to the administration
You likely can't join if
- Patients who have had chemotherapy or RT within 3 weeks ( or less than 1 week if on weekly chemotherapy) prior to start of the study agents. or...
- Patients received any other investigational agents within the past 4 weeks.
- Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Olaparib or ceralasertib.
- Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 (See Appendix A) are ineligible, unless...
- Current use of natural herbal products (see Appendix A) or other complementary alternative medications (CAM) or "folk remedies" should be...
See the full eligibility criteria
- Provision of informed consent prior to any study specific procedures
- Women age greater than 18 years with advanced/metastatic HER2 negative, BRCA germline positive breast cancer. Estrogen receptor positive (ER+) patients must have progressed on a prior endocrine therapy or are considered...
- Eligible patients must agree to a mandatory fresh biopsy (excluding bone) at screening. In addition, if available, an archival tissue sample will also be collected at screening.
- Patients must have normal organ and bone marrow function measured within 28 days (baseline screening) as defined below:
- Hemoglobin (Hgb) \>/= 10.0 g/dL with no blood transfusion in the past 28 days prior to the administration
- Absolute neutrophil count (ANC) \>/= 1.5 x 109/L with no GCSF administration within 28 days prior to administration of study treatment
- Platelet count \>/= 100 x 109/L
- Total bilirubin \</= 1.5 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) \ /= 16 weeks. 6) Negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on Cycle 1 day 1 and during...
- Female people must either be of non-reproductive potential (ie, post-menopausal by history: ≥ 60 years old and no menses for ≥1 year without an alternative medical cause; OR history of hysterectomy, OR history of...
- Patients who have had chemotherapy or RT within 3 weeks ( or less than 1 week if on weekly chemotherapy) prior to start of the study agents. or persisting \>/= Grade 2 CTCAE toxicity (except alopecia and Grade 2...
- Patients received any other investigational agents within the past 4 weeks.
- Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) scans...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Olaparib or ceralasertib.
- Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 (See Appendix A) are ineligible, unless discontinues within the washout period (2 weeks for CYP3A4 inhibitors and...
- Current use of natural herbal products (see Appendix A) or other complementary alternative medications (CAM) or "folk remedies" should be discontinued 7 days prior to the initiation of study drugs. 8) Patients with...
- 4cm in diameter, all the following criteria must be met:
- An ultrasound (US) within the last 6 months will be required to document that it is \</= 5cm
- Patient must be asymptomatic from the aneurysm. 13) A major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting study drug (percutaneous/endobronchial biopsies are allowed)...
- Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation...
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block). 26) Patients at risk of brain perfusion problems, e.g...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. 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.