The BioPER study

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The BioPER study “A Multicentre, International, Non-controlled Phase II Trial to Identify the Molecular Mechanisms of Resistance and Sensitivity to Palbociclib Re-challenge Upon Progression to a Palbociclib Combination in ER-positive Metastatic Breast Cancer Patients (BioPER)” reached its equator last 20th July 2018.

This is a proof of concept, international, open-label, non-controlled, multicenter phase II trial with two different primary objectives: a biological and a clinical objective. From a clinical point of view, the objective is to assess the clinical benefit of the combination of palbociclib and hormonotherapy in patients with advanced breast cancer that had previously received endocrine therapy in combination with palbociclib and had achieved clinical benefit during palbociclib treatment with subsequent disease progression. From a biological point of view, the challenge is to define a molecular profile that allows identifying patients that could benefit more from continuing on palbociclib after progression on a prior palbociclib-containing regimen. One of the main hurdles in recruitment is the need to obtain a biopsy at the time of progression to the previous palbociclib line to be eligible, making the screening and selection of participants a very stringent process.

From MedSIR, we would like to thank all the study teams for their continuous effort identifying putative patients. At the moment, IEO (Dr. Curigliano) in Italy and Hospital Duran i Reinals (Dr. Gil) and Hospital del Mar (Dr. Albanell) in Spain are the top recruiters of the study. Thanks to the commitment of all the Sites involved in BioPER, and the constant support from Pfizer, we are confident to reach the end of recruitment in December 2018.

The PHERGain Study

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We are pleased to announce that PHERGain study “Chemotherapy-free Trastuzumab and Pertuzumab in HER2-positive (Human Epidermal Receptor) Breast Cancer: FDG-PET Response-adapted Strategy” has achieved 40% of recruitment!!

The study assesses the early metabolic effects of neoadjuvant treatment with trastuzumab and pertuzumab (± endocrine therapy) on the primary tumor and axillary lymph nodes and their predictive value for a pathologic complete response (pCR) in the breast and axilla.

58 sites are planned to participate in the study and a total of 295 patients have been recruited (160 patients randomized and 116 screening failure) since June 2017. It’s a very interesting study that involves collaboration from Oncology, Radiology and Pathological Anatomy services. Thank you very much to all of them and specially to Hospital Virgen del Rocío (Dr Manuel Ruiz Borrego), Hospital Clínic Universitari de Valencia (Dr Begoña Bermejo), Hospital Vall Hebrón (Dr Santiago Escribà), Hospital Ramón y Cajal (Dra Noelia Martinez) and ICO L’Hospitalet (Dra Agostina Stradella) as top recruiters. The research team was supported by an unrestricted fellowship from Roche.

We will continue working on study recruitment and we count with your collaboration to finalize patient inclusion in December 2018 with 400 patients enrolled.

Dietary supplements and cancer: promises and realities

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A dietary supplement can be defined as any vitamin, mineral, protein, enzyme, probiotic, herb, or plant substance taken to supplement dietary needs or improve body functions. Although some dietary supplements may be injected, the vast majority come in the form of pills, powders and liquids that are ingested.

Dietary supplements are very widely used among patients with cancer and cancer survivors. Many perceive them to have potential anticancer activity, while many others use them to try to reduce the side effects of cancer treatment or to prevent the recurrence of new tumors. Although in some cases the use of these supplements is prescribed by doctors (when a cancer patient’s blood test results indicate a vitamin deficiency, for example), on many occasions cancer patients and survivors decide to use dietary supplements on their own, without any formal recommendation by their oncologists or primary care physicians.

It is relatively common for the dietary supplements in question to have shown antitumor activity in preclinical studies or small exploratory, nonrandomized, early-phase clinical trials. From these promising results, many supplements have been promoted for their purported ability to prevent (or even treat) cancer or ameliorate cancer treatment-derived side effects. Although the use of this kind of supplements among cancer patients and survivors is extremely common, robust information on their actual clinical efficacy is in many cases still very limited.

Oncologists are often challenged in providing advice to patients about which supplements are safe and effective to use to treat or prevent cancer or cancer therapy side effects, especially since favorable preclinical results usually do not translate to success in clinical trials. Additionally, in a clinical setting with treated patients, some supplements might even be antagonistic to standard treatment with chemotherapy, radiation, targeted therapy and/or immunotherapy. The lack of robust clinical results involving dietary supplements and cancer patients or survivors greatly complicates the job of medical professionals in advising about the efficacy and safety of their use.

The generation of solid clinical evidence on dietary supplements in cancer can therefore be considered an urgent, unmet need, although there are many challenges associated to the generation of such evidence. Impossibility for patent protection entails a lack of financial incentives to fund large clinical trials, and manufacturing difficulties might generate limited product consistencies, disputing the extrapolation of the results. Despite all these difficulties, the design and development of strategic, scientifically sound clinical trials able to shed some light into the convenience of using dietary supplements for cancer-related purposes is a necessity that all health-related stakeholders should address. Patients, physicians and health systems worldwide could greatly benefit from the potential results.

Roldan Cortés, MedSIR.


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C. J. Paller, S. R. Denmeade, y M. A. Carducci, «Challenges of conducting clinical trials of natural products to combat cancer», Clin Adv Hematol Oncol, vol. 14, n.o 6, pp. 447-455, jun. 2016.
E. D. Kantor, C. D. Rehm, M. Du, E. White, y E. L. Giovannucci, «Trends in Dietary Supplement Use Among US Adults From 1999-2012», JAMA, vol. 316, n.o 14, pp. 1464-1474, oct. 2016.
R. Kotecha, A. Takami, y J. L. Espinoza, «Dietary phytochemicals and cancer chemoprevention: a review of the clinical evidence», Oncotarget, vol. 7, n.o 32, pp. 52517-52529, may 2016.
S. Rautiainen, J. E. Manson, A. H. Lichtenstein, y H. D. Sesso, «Dietary supplements and disease prevention — a global overview», Nature Reviews Endocrinology, vol. 12, n.o 7, pp. 407-420, jul. 2016.

MedSIR INSIDE OUT – Alicia Garcia

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Today we are happy to spend a brief moment with Alicia Garcia, Head of Clinical Operations at MedSIR.

MedSIR Newsletter Team (MS): Thanks, Alicia, for spending some time with us here today.

Alicia Garcia (AG): Thank you, it’s my pleasure!

MS: What brought you to MedSIR?

AG: Prior to joining MedSIR, I had been working in mid and large size pharma companies for a long time and I was looking for a company with a different model. A company where I could feel more involved and contribute directly to improving the lives of patients.

MS: Interesting. So, it seems you have extensive experience in the field of clinical trials in Big Pharma. What was that change to a small company such as MedSIR like? Was it difficult for to you to make such a big jump?


AG: It obviously required a change of mindset. I moved from the very structured environment of Big Pharma, where every step had a defined process, to a small and very new company… I joined MedSIR in 2014. However, this has also been the most creative part: finding alternative solutions to old or new needs when implementing clinical trials. It has been challenging but also very rewarding.

MS: Sometimes our clients request us to define exactly how we work and what makes MedSIR so unique. How would you define MedSIR to our readers?

AG: I think that the name of MedSIR really contains one of its most valuable assets. This asset is Innovation. Innovation not only in the design of new therapeutic strategies that could improve the lives of patients, but also innovation in how clinical trials are implemented. At MedSIR, we are always open to new technologies, methodologies, and ideas that could make clinical research more efficient. There is a clear goal of generating, in a better and faster way, results that could improve clinical practice in Oncology.

MS: What’s your favorite thing about your job? And the worst thing?

AG: What I like the most is that no day is similar to the previous one. It is always necessary for all of us to keep learning and keep abreast of new clinical data and technologies. I also love the very close interactions with colleagues who have expertise in other areas. I love not only listening to our oncology experts discussing the rationale of new clinical trials, but also learning from colleagues working in finance or marketing.

What I like to avoid is too much bureaucratic work, and, fortunately, there is not too much of that (laughs).

MS: As Head of Clinical Operations, what do you think about your operational team (the Operations Team?)? Should some essential skills relevant to the International Trial Lead role be highlighted?

AG: I think I am very lucky to be part of such as a great group of people. The group is made of professionals with outstanding backgrounds in Biological or Clinical Research. There is always a “we can” attitude, nothing is seen as impossible. Even the most difficult situations are taken as a team challenge, where everyone is contributing their effort and enthusiasm to achieve a goal.

Even though we are not a large group, we are a very multicultural team. We have people from different countries and cultures including China, Argentina, Venezuela, Spain, Switzerland, The Dominican, etc… we even mix Barça and Real Madrid supporters or even some not interested in football at all… This diversity really is the source for the creativity and differential opinions that make up this team.

MS: And what about your hobbies? How do you distract your mind away from MedSIR?

AG: I am the mother of three children. This is a good way to free my mind from MedSIR (chuckles)… No, seriously, there are lots of things I like such as traveling or trekking. On one hand, I consider myself very Mediterranean in that what I enjoy most is being with my family and friends and participating in the life and events of my neighborhood. But, on the other hand, I also need my down time and I enjoy reading, running, and gardening.

MS: Thanks so much, Alicia, for your time!

Post ASCO 2018

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Barely 8 weeks after visiting the city for the AACR 2018 annual meeting, MedSIR returned to Chicago for ASCO 2018! McCormick Place is the largest convention center in North America, but at MedSIR we feel we already know all its nooks and crannies!

If this year’s AACR meeting was exciting, ASCO didn’t lag behind! The results of many new trials involving immune checkpoint inhibitors were presented, indicating that immunotherapy is the queen at the ball of current oncology. Pembrolizumab, for example, continued to show impressive results in lung cancer patients, including those at an early stage of the disease.

But not everything was related to immunotherapy! A new targeted therapy against PIK3CA (taselesib) was shown to slow the growth of advanced breast cancers, and innovative ways of using chemotherapy were shown to significantly extend the lives of patients with pancreatic cancer, one of the most deadly tumours.

One of the highlights of the Congress was the presentation of the results of the study TAILORx, which used Oncotype DX gene expression assay to prove that many women with early breast cancer can avoid chemotherapy without fear of worsening their prognosis. The findings will be a game-changer in breast cancer care, since from now on the use of chemotherapy can be directed only to the patients that will actually benefit from it.

But more important than the number of steps we walked going from one results presentation to another is the number of hands we shook with existing partners and potential new clients! We immediately got to work in building exciting relationships with both established companies and bold new players, in order to get the most out of the possibilities that all these advances offer to cancer patients worldwide! Feel free to contact us if you have an idea about the matter!

It was a great, successful, exhausting meeting, and therefore we can’t wait for ASCO 2019! See you all back next year in Sweet Home Chicago!