50% Recruitment Stage 1 in DxCARTES Study

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MedSIR is delighted to announce that DxCARTES study achieves a new milestone: 50% recruitment completed in stage 1. We currently have 15 patients recruited and 39 screenings have been sent to Central lab:

  • 11 Screening Failures
  • 8 patients at Cohort A
  • 8 patients at Cohort B
  • 19 Screening pending to be analyzed

DxCARTES is an international, multicenter, open-label, non-comparative, Simon´s two-stage design, phase II clinical trial with the objective to explore the ability of palbociclib in combination with letrozole to induce global molecular changes measured by either the Oncotype DX Breast Recurrence Score® (the “Assay”) test result at surgery (post-treatment Recurrence Score (RS) result), or pathological Complete Response (pCR) in patients with aggressive luminal tumors (intermediate or high pre-treatment RS result and Ki67>20) after 6 months of treatment.

We will continue working on study recruitment until we achieve a total of 26 patients enrolled in the first stage.

The study is currently approved in Spain but we expect to receive all the regulatory approvals from Portugal during July.

Thank you very much for the effort to all parties involved.

First Patient in BARBICAN Study

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We are very pleased to announce that the first two Spanish patients have been successfully randomized in the Study by Dr. Viñas and her team from Hospital Josep Trueta (ICO) last June and have started treatment in the study.

The BARBICAN study compares the addition of ipatasertib to atezolizumab plus neoadjuvant chemotherapy in patients with triple-negative breast cancer. The primary clinical endpoint is to compare pCR rates in the two treatment arms and determine whether adding the AKT-inhibitor ipatasertib to atezolizumab and chemotherapy increases the probability of immune response over adding atezolizumab alone. In addition, a biological co-primary endpoint would determine whether adding the AKT-inhibitor ipatasertib to atezolizumab and chemotherapy increases the probability of immune response over adding atezolizumab to chemotherapy in all treated patients.

Globally, the trial will enroll a total of 142 patients in three countries, (UK, Germany, and Spain) with an estimated accrual period of 12 months.

We would like to thank all the study teams for their interest and commitment in the study.

First Patient in REVERT study

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Welcome to the first patient in REVERT study. This is a multicenter, randomized, phase II trial evaluating the efficacy of eribulin monotherapy and eribulin plus endocrine therapy in locally- recurrent or metastatic breast cancer patients after progression on endocrine therapy.

The primary endpoint is the overall response rate (ORR) in the arm corresponding to the patients treated with eribulin in combination with aromatase inhibitor therapy (eribulin+ET arm), defined as the proportion of patients with best overall response of confirmed complete response or partial response based on local investigator’s assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.

On this study the eligible patients will be pre- and post-menopausal women with unresectable, ER-positive and/or PR-positive and HER2-negative locally-recurrent or metastatic breast cancer (mBC) with no prior line of chemotherapy in the metastatic setting and that has shown progression while on an aromatase inhibitor-containing regimen in the metastatic setting or within six months from last aromatase inhibitor dose in the adjuvant setting.

Hospital Ramón y Cajal (Madrid) has been enrolled the first patient, who started to receive the study treatment last June 24, 2019. The inclusion of this first patient is just the beginning of the next 15 months of enrollment in order to achieve the number of 60 patients randomized (22 in stage I and 38 in stage II) in 9 Spanish sites.

We highly appreciate the whole investigator team’s involvement especially in the set-up procedure of REVERT study.

ASCO Annual Meeting 2019 Highlights

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The 2019 Annual Meeting of the American Society of Clinical Oncology (ASCO) was characterized by a great number of presentations of novel and potentially practice-changing clinical trial data. The event was held from May the 30th till the 5th of June at the McCormick Place (Chicago), which is the largest convention center in North America.

One of the highlights of the Congress was the presentation by Roche of the results from a pre-specified exploratory analysis from the Phase III IMpower150 study. This data showed that the addition of Tecentriq to the combination of avastin and chemotherapy gave patients with chemotherapy-naïve non-small cell lung cancer (NSCLC) a striking survival benefit. After a disappointing high-profile phase III failure in ovarian cancer last year, lurbinectedin has become a therapeutic alternative for patients with small cell lung cancer (SCLC), a pathology with no second-line option for more than 20 years.

But not everything was related to lung cancer! An inhibitor of CDK4/6 from Novartis (Kisqali) in combination with hormone therapy extended the life of women with luminal metastatic breast cancer in the Phase III MONALEESA-7 trial. OS rates in the intent-to-treat population at 42 months were 70% in comparison to 46% for hormone therapy alone. Moreover, the addition of Kisqali to an aromatase inhibitor or tamoxifen reached 30% and 20.9% of the survival benefit of both combinations respectively.

Besides the highlights mentioned above, we also started to explore new cooperations with potentially interesting medical experts and different pharma/biotech companies while catching up with our existing partners. Most importantly, we will continue creating a robust network of professionals dedicated to improving the lives of cancer patients worldwide. We look forward to meeting you at the next ASCO congress!

A great moment for MedSIR in OM3d

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Once again, an unforgettable date in our calendars that the MedSIR team couldn’t miss out: The IV Foro en Oncología Médica en 3 Días (OM3d)! Year by year, the annual Foro is turning into one of the most important oncology congresses, where the brightest minds in this field come to present the latest updates in clinical research.

This year the event was celebrated at the beginning of May in Madrid and we could proudly say that we learned too many important things. First of all, the amazing presentation by Dr. Esther Holgado talking about innovation in the management of pain in cancer patients. She said: “we must understand the pain that may suffer our cancer patients. If a patient said that it hurts is because it really hurts”.

We had the opportunity to hear about the benefits of selecting and targeting the best biomarkers to effectively kill breast cancer cells, conducted by Dr. Aleix Prat. And Dr. Jose Manuel Perez Garcia gave us a nice shoot about all the therapeutic strategies to defeat HER2-positive breast cancer tumors depending on the subtype and phenotypic characteristics.

From Dr. Antonio Llombart we understood the reason to find a good biomarker to choose between chemotherapy and hormone therapy in neoadjuvancy. And of course, a terrific presentation by Dr. Javiér Cortés very focused on the explanation of the best treatment options when treating HER2+ breast tumors.

What an amazing team-training experience, we keep the nice taste of learning from the greatest minds in Spanish oncology. See you all next year to keep learning how to bring new ideas to life, and how to improve our cancer patient’s quality of life.

Dr. Javier Cortés

Dr. Javier Cortés

Dr. Aleix Prat