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New treatment option for Breast Cancer
Official title Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT05601440
What this study is testing
What is RP-6306?
RP-6306 is an investigational medicine, being studied as a potential treatment for breast cancer.
Also referred to as Lunresertib.
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 study is being done to answer the following question: Can testing breast cancer for DNA abnormalities or "biomarkers" help predict which patients are most likely to be helped by certain treatments? The pre-study screening is being done to test a sample of blood (or tumour tissue) for biomarkers to see if patients can participate in the study
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Patients must have histologically and/or cytologically confirmed, advanced / metastatic breast cancer, ER \>10% and not HER2 overexpressing/amplified...
- All patients must have a formalin fixed paraffin embedded tissue block (from primary or metastatic tumour) available and must have provided informed...
- Patients must have had objective disease progression demonstrated on (defined as while taking or within 8 weeks of the last dose) first line CDK4/6i...
- Presence of clinically and/or radiologically documented disease. All radiology studies must be performed within 21 days prior to enrollment (within...
- The criteria for defining measurable disease are as follows:
You likely can't join if
- Patients with a history of other malignancies, including Myelodysplastic syndrome (MDS) or Acute myeloid leukemia (AML) except: adequately treated...
- Patients with active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed...
- Infection includes but is not limited to active infection requiring systemic therapy and active or known human immunodeficiency virus (HIV) with...
- Pneumonitis or any history of pneumonitis requiring steroids (any dose)
- Participant has received a live attenuated vaccine within 30 days of planned start of study therapy. Note: Seasonal vaccines for influenze are...
- Known primary immunodeficiency
See the full eligibility criteria
Who can join
- Patients must have histologically and/or cytologically confirmed, advanced / metastatic breast cancer, ER \>10% and not HER2 overexpressing/amplified as per ASCO/CAP criteria. Patients with locally advanced or...
- All patients must have a formalin fixed paraffin embedded tissue block (from primary or metastatic tumour) available and must have provided informed consent for the release of the block
- Patients must have had objective disease progression demonstrated on (defined as while taking or within 8 weeks of the last dose) first line CDK4/6i + ET for MBC. Patients who discontinued CDK4/6i + ET without disease...
- Presence of clinically and/or radiologically documented disease. All radiology studies must be performed within 21 days prior to enrollment (within 28 days if negative). All patients must have measurable disease as...
- The criteria for defining measurable disease are as follows:
- Chest x-ray ≥ 20 mm
- CT scan (with slice thickness of 5 mm) ≥ 10 mm: longest diameter
- Physical exam (using calipers) ≥ 10 mm
- Lymph nodes by CT scan ≥ 15 mm: measured in short axis
- Patients must be ≥ 18 years of age
- Patients must have an ECOG performance status 0 or 1
- Patients must have a life expectancy ≥ 3 months.
- Hemoglobin ≥90 g/L\
- Absolute neutrophils ≥ 1.5 x 10\^9/L (1500/µL)
- Platelets ≥ 100 x 109/L (100 x 10\^3/µL)
- Bilirubin ≤ 1.5 x ULN (upper limit of normal)\ \
- AST \& ALT ≤ 2.5 x ULN
- ≤ 5.0 x ULN if patient has liver metastases
- Serum creatinine ≤ 1.5 x ULN, Creatinine clearance ≥50 mL/min
- All patients must have received at least 24 weeks of prior CDK4/6i in combination with first line ET for advanced or metastatic disease and have had disease progression on or within 8 weeks of the last dose of CDK4/6i...
- For enrollment to "second line" substudies: \- An additional single agent non-fulvestrant/SERD endocrine therapy in the palliative setting is permitted provided patient remains eligible for and can access fulvestrant...
- For enrollment to "third line" substudies:
- Non-SERD endocrine therapy and targeted agents (for example, PI3K/AKT/PTEN inhibitors unless excluded in substudy-specific eligibility criteria) alone or in combination.
- Patients who have received a prior targeted agent may not be eligible for substudies that contain the same class of agent. Please refer to substudy-specific eligibility criteria.
- Note: if a patient has not had fulvrestrant/SERD prior to enrollment to "third line: substudy, single agent fulvestrant/SERD must be given prior to enrollment (unless not possible for reasons such as fulvestrant/SERD...
- Patients may also have received adjuvant/neoadjuvant systemic therapies; however cytotoxic chemotherapy or antibody drug conjugates (ADC) in the palliative setting are not permissible.
- Patients receiving LHRH agonists (for example premenopausal patients) may continue on the LHRH agonist, but may not start a LHRH agonist within 12 weeks prior to enrollment.
- Consult CCTG for other scenarios (for example where short course of other ET is given prior to CDKi + ET, patients who have received investigational drugs, vaccines or immunotherapies) as certain patients may be...
- All reversible prior toxicity related to prior therapies must have recovered to grade ≤ 1 (consult CCTG in the case of irreversible toxicity) and have adequate washout as follows (screening may occur during the washout...
- Patients must not have received a transfusion (platelets or red blood cells) or colony stimulating factors ≤ 4 weeks prior to initiating treatment substudy therapy.
- Surgery: Prior surgery is permitted provided that a minimum of at least 28 days have elapsed between any major surgical procedure and date of enrollment, and that wound healing has occurred.
- Radiation: Prior external beam radiation is permitted provided a minimum of 28 days (4 weeks) have elapsed between the last dose of radiation and date of enrollment. Exceptions may be made for low-dose...
- Patients must be registered and provide consent prior to blood collection for screening. The screening blood sample cannot be sent for analysis prior to screening registration.
- Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to both screening registration as well as enrollment to a...
- Patients must be accessible for treatment and follow up. Patients enrolled on this trial must be treated and followed at the participating centre
- In accordance with CCTG policy, substudy treatment is to begin within 2 working days of patient enrollment.
- Women/men of childbearing potential must have agreed to use a highly effective contraceptive method.
What rules you out
- Patients with a history of other malignancies, including Myelodysplastic syndrome (MDS) or Acute myeloid leukemia (AML) except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the...
- Patients with active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to protocol.
- Infection includes but is not limited to active infection requiring systemic therapy and active or known human immunodeficiency virus (HIV) with detectable viral load, known hepatitis B surface antigen or positive...
- Pneumonitis or any history of pneumonitis requiring steroids (any dose)
- Participant has received a live attenuated vaccine within 30 days of planned start of study therapy. Note: Seasonal vaccines for influenze are generally inactivated vaccines and are allowed. Intranasal vaccines are live...
- Known primary immunodeficiency
- Patients with recent clinically significant cardiac disease, including:
- Angina pectoris, symptomatic pericarditis, coronary artery bypass grafting, coronary angioplasty, or stenting, or myocardial infarction in the previous 12 months;
- History of documented congestive heart failure (New York Heart Association functional classification III-IV) or cardiomyopathy
- Uncontrolled hypertension (per Canadian guidelines)
- All patients should have a LVEF ≥ 50%.
- Patients with HER2 positive breast cancer (based on the most recent assessment, according to ASCO/CAP criteria).
- History of hypersensitivity to any of the study drugs or their components.
- Patients may not receive concurrent treatment with other anti-cancer therapy (other than bone-targeted therapy, if already taking and stable) or investigational agents while on protocol therapy.
- Patients with prior allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
- Pregnant or breastfeeding women (including within 1 month following last dose of protocol therapy).
- Patients with history of central nervous system metastases or spinal cord compression unless they have received definitive treatment such as resection or radiation, are clinically stable and do not require...
- Patients who are unable to swallow oral medication and/or have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g. Crohn's disease, ulcerative...
- Patients with a history of non-compliance to medical regimens.
- See Section 7.3 and individual treatment substudies for a list of concomitant medications that are not permitted.
- Many substudies include drugs that have a risk for thrombocytopenia; therefore, participants should be advised to use caution when taking oral anticoagulants (e.g. warfarin) and antiplatelet drugs (e.g. aspirin)...
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Kelowna, British Columbia, Canada
- Vancouver, British Columbia, Canada
- Halifax, Nova Scotia, Canada
- Hamilton, Ontario, Canada
- Kingston, Ontario, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
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 all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Kelowna, British Columbia, Canada; Vancouver, British Columbia, Canada; Halifax, Nova Scotia, Canada; Hamilton, Ontario, Canada; Kingston, Ontario, Canada and 3 more location(s). 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.