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Tests treatment safety and results for Breast Cancer
Official title A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population
ClinicalTrials.gov ID: NCT05708235
What this study is testing
What is Giredestrant?
Giredestrant is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for breast cancer.
Also referred to as GDC-9545.
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 trial is a multicenter, open-label, non-comparative, phase II, biomarker-driven adjuvant treatment study involving the periodic collection and analysis of blood samples from patients with HR-positive/HER2-negative early-stage BC at higher risk of relapse, who have undergone surgery within the previous five years, with no evidence of locoregional, contralateral, or distant disease. The study design is composed by an initial pre-screening phase, a molecular follow-up phase (ctDNA surveillance phase), and an interventional therapeutic phase (treatment phase).
- 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
Ages 18 and older
You may be able to join if
- Eligibility criteria for the surveillance phase: Note: Patients who have not participated in the surveillance phase but have a positive ctDNA test...
- Signed informed consent form (ICF) prior to participation in any Studyrelated activities.
- Male or female patients aged 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Histologically proven primary HR-positive according to the updated American Society of Clinical Oncology (ASCO)/College of American Pathologists...
You likely can't join if
- for surveillance phase:
- Patients with pathological complete response (pCR) after neoadjuvant treatment.
- Any concurrent or planned treatment for the current diagnosis of BC other than adjuvant ET except for denosumab or zoledronic acid, which are allowed.
- Diagnosis of an alternative cancer in the five years prior to primary BC diagnosis other than for non-melanoma carcinoma of the skin or cervical...
- Active or prior documented inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis, or a preexisting chronic condition resulting in...
- Active cardiac disease or history of cardiac dysfunction including any of the following:
See the full eligibility criteria
Who can join
- Eligibility criteria for the surveillance phase: Note: Patients who have not participated in the surveillance phase but have a positive ctDNA test (conducted under other circumstances) will be allowed to enter directly...
- Signed informed consent form (ICF) prior to participation in any Studyrelated activities.
- Male or female patients aged 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Histologically proven primary HR-positive according to the updated American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2020 guidelines and HER2-negative BC as per ASCO/CAP 2018 criteria...
- Patients with high-risk early-stage BC according to at least one of the following criteria: a. If there is no previous neoadjuvant chemotherapy: i. pN2-N3 or ii. pN1 (including micrometastasis - pN1mi) if: 1\. pT3-T4...
- cT3-4, or
- cT2 and high genomic risk and / or histological grade III and / or Ki67≥30%. Note: Genomic risk using platforms such as Oncotype Dx, Prosigna or Mammaprint won't be assessed for the screening to participate in the...
What rules you out
- for surveillance phase:
- Patients with pathological complete response (pCR) after neoadjuvant treatment.
- Any concurrent or planned treatment for the current diagnosis of BC other than adjuvant ET except for denosumab or zoledronic acid, which are allowed.
- Diagnosis of an alternative cancer in the five years prior to primary BC diagnosis other than for non-melanoma carcinoma of the skin or cervical carcinoma in situ. Other stage I tumors will be discussed case by case...
- Active or prior documented inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis, or a preexisting chronic condition resulting in baseline grade ≥1 diarrhea) that may significantly alter the absorption...
- Active cardiac disease or history of cardiac dysfunction including any of the following:
- History (within two years from screening) or presence of idiopathic bradycardia or resting heart rate \<50 beats per minute at screening.
- History of angina pectoris or symptomatic coronary heart disease within 12 months prior to Study entry.
- QT interval corrected through use of Fridericia's formula (QTcF) \> 450 ms for women and \> 470 ms for men by at least three electrocardiograms (ECGs) \> 30 minutes apart.
- History or presence of an abnormal ECG that is clinically significant in the investigator's opinion,
- History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease (e.g., severe left ventricular systolic dysfunction, left ventricular hypertrophy cardiomyopathy...
- History of pneumonitis, interstitial lung disease (ILD), or pulmonary fibrosis.
- Known history of Human Immunodeficiency Virus (HIV) infection (testing not required as part of Study screening).
- Clinically significant liver disease consistent with Child-Pugh C, including active hepatitis (e.g., hepatitis B virus [HBV] or hepatitis C virus [HCV]), current alcohol abuse, cirrhosis, or positive test for viral...
- Active bleeding diathesis venous thrombo-embolism, previous history of bleeding diathesis, or chronic anti-coagulation treatment, or any indications or history of Disseminated Intravascular Coagulation (DIC) or Deep...
- Creatinine clearance \< 30mL/min.
- Participants with renal dysfunction who require dialysis.
- Patient who has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator' opinion cause unacceptable safety risks, contraindicate patient participation in the clinical trial or...
- Females who are known to be breastfeeding or pregnant as determined by a serum pregnancy test, Human chorionic gonadotropin (β-HCG), prior to the administration of any trial treatment (once during the treatment phase)...
- Female or male participants planning a pregnancy. Eligibility criteria for the treatment phase: Patients will be considered eligible to enter to the treatment phase and to be allocated to standard ET only followed by...
- Signed treatment ICF prior to Study inclusion.
- Male or female patients aged 18 years or older.
- ctDNA positivity with no evidence of clinical or radiologic recurrence by standard assessments (e.g.: breast ultrasound, staging scans, RMN).
- ECOG performance status 0 or 1.
- Patients must have received the same ET during at least the last 6 months. A temporary discontinuation of \< 90 days during the surveillance phase is allowed.
- Receiving LHRH agonist therapy alongside the same ET treatment for at least 90 days prior to initiation of one of the available Study treatments if male or pre-menopausal.
- Prior treatment with cyclin-dependent kinases 4/6 (CDK4/6) inhibitors will be allowed in the case of an interval of at least 12 months between the last dose and inclusion in the trial.
- No prior treatment with SERDs will be allowed.
- Absence of metastatic disease by routine clinical assessment (computed tomography [CT] scan of the thorax and abdomen, and bone scan or positron emission tomography [PET] scan). confirmed no longer than three months...
- Patients must have had surgery for their primary BC with documented clear margins (as per local guidelines) ) and they must have received radiotherapy if indicated (as per local guidelines).
- Willingness and ability to provide tissue from one archival tumor tissue sample (either from diagnostic biopsy, primary surgery, or where available from a residual disease post-neoadjuvant therapy).
- Female of reproductive potential and male patients with female partners of childbearing potential, must remain abstinent and truly abstain from sexual activity (refrains from heterosexual intercourse) or use...
- Resolution of all acute toxic effects of prior anti-cancer therapy to Grade ≤1 as determined by the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 5.0 (except for...
- Adequate hematologic and organ function within 14 days before the first Study treatment on Day 1 of Cycle 1, defined by the following:
- Hematological (without platelet, red blood cell (RBC) transfusion, and/or granulocyte colony-stimulating factor support within 7 days before first Study treatment dose): White blood cell (WBC) count \> 3.0 x 109/L...
- Hepatic: Serum albumin ≥ 3 g/dL; Bilirubin ≤ 1.5 times the upper limit of normal (ULN) (≤ 3 x ULN in the case of Gilbert's disease); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × ULN; alkaline...
- Renal: serum creatinine level ≤ 1.5 × the upper limit of normal (ULN) or an estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m², as calculated using the 2021 CKD-EPI creatinine equation (National Kidney...
- Participants who are able and willing to swallow, retain, and absorb oral medication.
- Patients must be able and willing to adhere to Study procedures. Additional inclusion criteria for Arm C (giredestrant + abemaciclib arm): 1\. Patients with prior diagnosis of thrombosis might be included as long as...
- Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test: Qiagen therascreen PIK3CA RGQ PCR PCR kit - CE-IVD). This determination will be done in tumor tissue.
- No prior treatment with any phosphatidylinositol 3-kinase (PI3K), Akt, or mammalian target of rapamycin (mTOR) inhibitors, or any agent whose mechanism of action is to inhibit the PI3K/Akt/mTOR pathway. Exclusion...
- Known hypersensitivity reaction to any investigational or therapeutic compound or their incorporated substances.
- Undergoing any other simultaneous anti-cancer treatment since enrolling in the Study, other than hormonal therapy or a bisphosphonate (or denosumab).
- Major surgery (defined as requiring general anesthesia) or significant traumatic injury within 28 days of start of Study drug, or patients who have not recovered from the side effects of any major surgery.
- Treatment with strong Cytochrome P450 3A4 (CYP3A4) inhibitors or strong CYP3A4 inducers within 14 days or five drug-elimination halflives, whichever is longer, prior to initiation of one of the available Study...
- Patient has a history of non-compliance to medical regimen. Additional exclusion criteria for Arm D (giredestrant + inavolisib arm):
- Type 2 diabetes requiring ongoing systemic treatment at the time of Study entry; or any history of Type 1 diabetes.
- Fasting glucose ≥126 mg/dL or ≥7.0 mmol/L and hemoglobin A1C (HbA1c) ≥ 6.0%.
- Any concurrent ocular or intraocular condition excluding cataracts (e.g., diabetic retinopathy) that, in the opinion of the investigator, would require medical or surgical intervention during the Study period to prevent...
- Active inflammatory (e.g., uveitis or vitritis) or severe infectious conditions (e.g., keratitis, scleritis, or endophtalmitis) in either eye or history of idiopathic or autoimmune-associated uveitis in either eye.
- Inability to confirm biomarker eligibility based on valid results from either central testing of blood or local testing of blood or tumor tissue that documents one of the protocol-defined PIK3CA mutations.
The study team makes the final eligibility decision.
Where it's taking place
- A Coruña, Spain
- Alicante, Spain
- Barcelona, Spain
- Bilbao, Spain
- Castellon, Spain
- Córdoba, Spain
- Elche, Spain
- Girona, Spain
- Granada, Spain
- Jaén, Spain
- León, Spain
- Lleida, Spain
- Madrid, Spain
- Málaga, Spain
- Murcia, Spain
- Pamplona, Spain
- Sagunto, Spain
- Seville, Spain
- Tarragona, Spain
- Valencia, Spain
+ 6 more site(s).
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include A Coruña, Spain; Alicante, Spain; Barcelona, Spain; Bilbao, Spain; Castellon, Spain; Córdoba, Spain and 20 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.