Biomarker Monitoring for Breast Cancer Recurrence Risk
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Abramson Cancer Center at Penn Medicine
Must not be taking: Corticosteroids, Hydroxychloroquine
Disqualifiers: Uncontrolled diabetes, Cardiovascular risk, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This is a single center, prospective cross-sectional study of women who have completed therapy for primary breast cancer within 5 years of diagnosis and are at increased risk for relapse.
Patients will undergo screening bone marrow aspirate to test for presence of disseminated tumor cells (DTCs) Patients who harbor DTCs will be offered the opportunity for enrollment into a clinical trial of therapy targeting DTCs to prevent recurrence (separate protocols).
Will I have to stop taking my current medications?
The trial allows participants to continue taking adjuvant endocrine therapy and bone modifying agents as part of standard care. However, if you are taking tamoxifen and are DTC positive, you may need to stop it if your doctor agrees. Other medications, like certain anticoagulants, may need to be paused around the time of specific procedures.
Is olaparib (Lynparza) generally safe for humans?
Olaparib (Lynparza) has been studied for safety in various cancers, including ovarian and breast cancer. It is generally considered safe, but like all medications, it can have side effects, which may include nausea, fatigue, and anemia (low red blood cell count).
12345How does the biomarker monitoring treatment for breast cancer recurrence risk differ from other treatments?
This treatment is unique because it uses a blood-based biomarker assay, like DiviTum TKa, to monitor and predict treatment response, potentially reducing the need for traditional disease monitoring and avoiding unnecessary treatments. It focuses on using circulating biomarkers to improve risk assessment and tailor treatments more effectively for breast cancer patients.
678910Eligibility Criteria
This trial is for women who finished breast cancer treatment within the last 5 years, have no signs of recurrence, and are at high risk of relapse. They must be willing to undergo bone marrow aspiration and blood tests, meet specific receptor criteria, and have good organ function. It's not for those with severe health issues, on other trials or certain medications, with cardiovascular risks or a history of lung disease.Inclusion Criteria
I was diagnosed with invasive breast cancer in the last 5 years.
I finished my main cancer treatment at least 4 weeks ago.
My cancer has not returned after treatment.
+4 more
Exclusion Criteria
Severe and/or uncontrolled medical conditions or other conditions that could affect participation in the study
I have had lung inflammation or severe lung problems.
My diabetes is not under control.
+16 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
1 visit (in-person)
Bone Marrow Aspirate
Patients undergo bone marrow aspirate to test for disseminated tumor cells (DTCs) by immunohistochemistry
1 day
1 visit (in-person)
Follow-up
Participants are monitored for the presence of disseminated tumor cells annually
5 years
Annual visits (in-person)
Participant Groups
The study involves collecting blood samples from participants to check for disseminated tumor cells (DTCs) in the bone marrow. Women found to have DTCs may join further trials targeting these cells to prevent cancer recurrence.
1Treatment groups
Experimental Treatment
Group I: Screening Bone Marrow AspirateExperimental Treatment1 Intervention
All patients will undergo screening bone marrow aspirate to test for disseminated tumor cells (DTCs) by immunohistochemistry. The bone marrow sample is also used for other research tests.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, PA
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Who Is Running the Clinical Trial?
Abramson Cancer Center at Penn MedicineLead Sponsor
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
References
Olaparib maintenance monotherapy in platinum-sensitive, relapsed ovarian cancer without germline BRCA mutations: OPINION Phase IIIb study design. [2020]The poly(ADP-ribose) polymerase inhibitor olaparib (Lynparza™) is approved for maintenance treatment of platinum-sensitive relapsed ovarian cancer. OPINION is a single-arm, open-label, multicenter, Phase IIIb study to assess the efficacy and safety of olaparib tablet maintenance therapy in women with high-grade serous or endometrioid platinum-sensitive relapsed ovarian cancer without a germline BRCA1 or BRCA2 mutation. Eligible patients should have received ≥2 prior lines of platinum-based chemotherapy and be in complete or partial response following their most recent course or have no evidence of disease. Patients will receive olaparib tablets (300 mg twice daily) until disease progression, unacceptable toxicity or another discontinuation criterion. The primary end point is investigator-assessed progression-free survival; secondary end points include progression-free survival according to tumor homologous recombination deficiency status. Clinical trial registration: NCT03402841.
New Adjuvant Treatment for High-Risk Early Breast Cancer. [2022]Olaparib (Lynparza) is now approved for the adjuvant treatment of adult patients who have, or are suspected to have, the germline variation of BRCA-mutated human epidermal growth factor receptor 2-negative high-risk early breast cancer and who were previously treated with neoadjuvant or adjuvant chemotherapy.
Olaparib: first global approval. [2020]Olaparib (Lynparza™) is an oral, small molecule, poly (ADP-ribose) polymerase inhibitor being developed by AstraZeneca for the treatment of solid tumours. The primary indication that olaparib is being developed for is BRCA mutation-positive ovarian cancer. A capsule formulation of the drug has received approval for use in this setting in the EU and USA, and a tablet formulation is in global phase III trials (including in the USA, EU, Australia, Brazil, Canada, China, Israel, Japan, Russia and South Korea). In addition, phase III trials in breast, gastric and pancreatic cancer are underway/planned, and phase I/II investigation is being conducted in other malignancies, including prostate cancer, non-small cell lung cancer, Ewing's sarcoma and advanced cancer. This article summarizes the milestones in the development of olaparib leading to this first approval for ovarian cancer.
Phase I/Ib study of olaparib and carboplatin in women with triple negative breast cancer. [2019]Label="PURPOSE" NlmCategory="OBJECTIVE">To investigate the safety, activity, and potential biomarkers of response to olaparib and carboplatin combination in sporadic triple negative breast cancer (TNBC). EXPERIMENTAL DESIGN: Metastatic or recurrent TNBC patients with no germline BRCA mutation or with BRCAPro scores <10% and a negative family history were eligible. A 3+3 dose escalation tested olaparib capsules (400mg bid, days1-7) with carboplatin AUC3-5 on day1 or 2 every 21 days, ≤ 8 cycles, with olaparib 400mg bid maintenance. Peripheral blood mononuclear cells were collected for polymorphisms and PAR levels, and paired tumor biopsies (pre-/post-cycle 1) for proteomics and apoptosis endpoints.
Candidate biomarkers of PARP inhibitor sensitivity in ovarian cancer beyond the BRCA genes. [2020]Olaparib (Lynparza™) is a PARP inhibitor approved for advanced BRCA-mutated (BRCAm) ovarian cancer. PARP inhibitors may benefit patients whose tumours are dysfunctional in DNA repair mechanisms unrelated to BRCA1/2. We report exploratory analyses, including the long-term outcome of candidate biomarkers of sensitivity to olaparib in BRCA wild-type (BRCAwt) tumours.
Budget impact analysis of the DiviTum TKa assay in postmenopausal women with hormone receptor positive metastatic breast cancer. [2022]DiviTum TKa, a blood-based biomarker assay developed to monitor and predict treatment response in hormone receptor positive metastatic breast cancer (HR + mBC), may decrease traditional disease monitoring assessments and avoid prolongation of futile treatments.
Circulating biomarkers at diagnosis correlate with distant metastases of early luminal-like breast cancer. [2023]There is an urgent need for new and better biomarker modalities to estimate the risk of recurrence within the luminal-like breast cancer (BC) population. Molecular diagnostic tests used in the clinic lack accuracy in identifying patients with early luminal BC who are likely to develop metastases. This study provides proof of concept that various liquid biopsy read-outs could serve as valuable candidates to build a multi-modal biomarker model distinguishing, already at diagnosis, between early metastasizing and non-metastasizing patients. All these blood biomarkers (chemokines, microRNAs, leukemia inhibitory factor, osteopontin, and serum-induced functional myeloid signaling responses) can be measured in baseline plasma/serum samples and could be added to the existing prognostic factors to improve risk stratification and more patient-tailored treatment in early luminal BC.
Efficacy of nab-paclitaxel does not seem to be associated with SPARC expression in metastatic breast cancer. [2015]To evaluate the predictive value of the expression of the secreted protein acidic and rich in cysteine (SPARC) for nab-paclitaxel in metastatic breast cancer (MBC).
CD49f Can Act as a Biomarker for Local or Distant Recurrence in Breast Cancer. [2020]Metastasis and local recurrence are the primary causes of treatment failure and patient death in breast cancer. The aim of this study was to validate a metastasis- and local recurrenceassociated biomarker for prognostic evaluation and planning treatment strategies.
Comparison of StemPrintER with Oncotype DX Recurrence Score for predicting risk of breast cancer distant recurrence after endocrine therapy. [2022]Molecular tests predicting the risk of distant recurrence (DR) can be used to assist therapy decision-making in oestrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer patients after considerations of standard clinical markers. The Oncotype DX Recurrence Score (RS) is a widespread tool used for this purpose. Here, we compared the RS with the StemPrintER Risk Score (SPRS), a novel genomic predictor with a unique biological basis in its ability to measure the expression of cancer stemness genes.