REtrospective Study to Evaluate the Molecular Differences Between PET-POsitive and PET-Negative Tumor Samples from HER2-Positive Breast Cancer Patients within the PHERGain Trial (The RESPONSE Study).
About 14,69% of patients screened for PHERGain study had failed to enter because of non-measurable disease by Positron Emission Tomography (PET) criteria (PERCIST). Early PET-SCAN evaluation has shown to be a strong predictor of pathological Complete Response (pCR) to neoadyuvant chemotherapy in early breast cancer.
As initial estimations on screening failures by PET were underestimated, we need to explore the clinical, pathological and molecular characteristics of these screening failures in order to manage a more adequate patient selection. Several hypotheses can be suggested, from the high heterogeneity in term of molecular signatures and metabolic pathways, to a strong relationship between smaller or more indolent tumors and molecular or pathological characteristics.
In order to prove our hypothesis, firstly we will review retrospectively all clinical, radiological and pathological characteristics of the first 60 patients with a screening failure by PET criteria. This revision will include: i) a centralized and independent imaging analysis for Magnetic Resonance Imaging (MRI) (in order to confirm the tumor size ≥1.5 centimeter) and PET (Standardized Uptake Value maximum [SUVmax] value detected); ii) collection of data about Estrogen Receptor (ER) and Progesterone Receptor (PgR) status, Ki67 proliferation marker and fluorescence in situ hybridization (FISH)-HER2 status. Then, on the basis of clinicopathological characteristics we will match the first 60 screening failures to the first 200 patients included in order to identify potential markers of screening failure by PET.
Secondly, if consistency data is not obtained, we will analyze the molecular and metabolic profiles of those tumors from both cohorts of patients. Considering the clinically and biologically heterogeneous status of HER2-positive disease, the characterization of the metabolome, which constitutes the downstream products of cellular functions, together with the genotype and phenotype can provide a better understanding of which subgroup of patients might not need chemotherapy if treated with dual HER2 blockade, and endocrine therapy if necessary.
We are glad 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 65% of recruitment!! (266/400 patients).
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.
50 sites are active and recruiting in 7 countries (Spain, France, Italy, Portugal, Belgium, UK and Germany) only 5 sites pending in Portugal to participate in the study and a total of 266 patients have been recruited (453 patients screened, 165 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 (31 patients randomized), Hospital Clínic Universitari de Valencia – Dr Begoña Bermejo (18 patients randomized), Hospital Vall Hebrón – Dr Santiago Escrivà (16 patients randomized), Hospital Ramón y Cajal – Dr Noelia Martinez (15 patients randomized) and ICO L’Hospitalet – Dr Agostina Stradella (19 patients randomized) as top 5 recruiters. The research team was supported by an unrestricted fellowship from Roche.
In March 2019 we expect to have 400 patients enrolled in the study thanks to continuing working with your collaboration. We will make it!
Since 1977, the Symposium’s mission has been to provide state-of-the-art information on the experimental biology, etiology, prevention, diagnosis, and therapy of breast cancer and premalignant breast disease. From a one-day regional conference, the Symposium has grown to a five-day program attended by a broad international audience of more than 7.500 both academic and private researchers and physicians from over 90 countries.
MedSIR will be attending this 41st Annual event from December 04 – 08, 2018 at Henry B. Gonzalez Convention Center, San Antonio, Texas, USA.
We are very excited to be part of such an important Symposium to meet with so many
Investigators and established Pharma companies, as well as up-and-coming Biotechs. The table is set for an unbelievable 5 days under the Texan sun.
Apart from our daily interactions, some of the key highlights that will be presented are:
- Subgroup analysis of phase III MONALEESA trials
- Biomarker analyses from the phase III randomized MONALEESA-7 trial
- Subgroup analyses from the Phase III SOLAR-1 trial
- TAVO™ as a monotherapy and an initial project overview for KEYNOTE-890, a Phase 2 clinical trial in combination with pembrolizumab for the treatment of triple negative breast cancer (TNBC).
- New eribulin mesylate study results about differential effects of eribulin on key transcription factors snail and slug and a phase 3 trial to compare eribulin mesylate + trastuzumab (H) + pertuzumab (P) with paclitaxel or docetaxel + HP for HER2-positive advanced or metastatic breast cancer (JBCRG-M06/EMERALD)
- Impassion130: Efficacy in immune biomarker subgroups from the global, randomized, double-blind, placebo-controlled, phase III study of atezolizumab + nab-paclitaxel in patients with treatment-naïve, locally advanced or metastatic triple-negative breast cancer
And much, much more…
See you all there!!
We are pleased to announce that EXCAAPE study “A phase II clinical trial of radium-223 activity in patients with metastatic castration-resistant prostate cancer (mCRPC) with asymptomatic progression while on abiraterone acetate or enzalutamide besides AR-V7 mutational status” has achieved 100% of recruitment!
9 Spanish sites have participated and a total of 63 patients have been recruited (52 treated and 11 Screening Failure) since December 2016. It’s been a long journey with many difficulties but the perseverance and effort of the site investigators and collaborators have been the main key to achieve it.
From the MedSIR team, we would like to thank all the study teams for their implication and effort identifying patients, who can benefit from their participation. In special, we would like to thank to Hospital Vall Hebrón (Dr Joan Carles Galcerán), Hospital Ramón y Cajal (Dr Teresa Alonso) and Hospital Clínic de Barcelona (Dr Begoña Mellado) for their commitment and for being the top recruiters. Other special thanks to Bayer for their continuous support during the conduct of the trial.
Today we are happy to spend a brief moment with Duna Zaragoza, Head of Human Resources at MedSIR…we all known her as People Manager.
MedSIR Newsletter Team (MS): Thanks, Duna, for spending some time with us here today.
Duna Zaragoza (DZ): Thank you, it’s my pleasure!
MS: Well Duna, we know that you are officially the first employee of MedSIR. Tell us… What brought you to MedSIR?
DZ: The truth is that I remember my beginnings in MedSIR with a lot of love and a certain nostalgia. I know personally two of the four MedSIR partners because I worked with them on a previous occasion. When they explained their project to me, at the beginning it was difficult for me to understand because I had worked in a CRO and, although some may think a priori that they are similar companies, they are not. The concept behind MedSIR is completely different.
I started in MedSIR in 2012. At that time we did not have an office, everything was home based… Not many projects… We started with just one, and it did not take very long before two more very signed.
We were such a small group at our first Christmas meal that we didn’t even have to book a restaurant in advance! Hahaha.
Not a year passed that we already had an office in the Barcelona Biomedical Research Park (PRBB) and the staff was growing, until today. Six years later we are in an office three times bigger than the previous one (which is too small for us) and almost 30 people have joined.
MS: Within the company, you have gone through several departments … In which one did you stay? If you had to do it all over again, would you change anything?
DZ: I started working at MedSIR as a Project Manager and after 3 years I realized that I needed a change.
One of the qualities of MedSIR as a company, and one that is most important for me is that from the beginning people listen to you and take an interest in your professional growth. This is the reason why after discussing it with directors, the opportunity arose to continue my career at MedSIR by joining the Department of Human Resources and Training, and in the Quality Department.
I could not tell you which of them I would stay with, because what I like most is the versatility of activities that I can do in each of them. It is a nonstop learning experience that I enjoy and that motivates me.
MS: Sometimes our clients ask us to define exactly how we work and what sets us apart. How would you define MedSIR to our readers?
DZ: If you allow me to make an informal definition…. because you will on our website the formal description… I would say that within our sector we are an unconventional company. For starters, we are the sponsors of most projects, and therefore have a vested interested in ensuring that our clinical trials are successfully carried out, without ever losing sight of our main purpose, which is to improve the patient’s lives.
There is a phrase that is mentioned many times when customers or suppliers come to see us and it is: what beautiful offices you have!, how much light! and … how much silence… It is a first impression that is repeated frequently and I totally agree. In MedSIR there are days when, instead of being in an office, you seem to be in a library because everyone is very focused in what they are doing. There is a good atmosphere and the fact that we work in an open space allows us to interact with everyone.
I have many anecdotes to share but without a doubt, for me, the best moments arise when we all meet once a month to share knowledge in one-hour sessions, and any of us can explain a topic of their interest to the rest of the team.
MS: What’s your favorite thing about your job? And the worst thing?
DZ: I will start with what I like least in the Human Resources Department. The worst has to do with personnel departures, or how to act in low yields (what do you mean? Poor performance?). It is not always easy to handle these two issues. Because of the General Quality System, the revision and modification of the SOPs.
In general, what I like the most about my job is that the tasks performed are not very repetitive and I am always learning new things.
For me, the best thing about working in human resources are the people itself. We have to be aware that they are the main asset of companies and that it is important to listen and meet their needs.
MS: As People Manager, we would like to know your opinion about the MedSIR Team. Is there any particular feature that all of them share? Do you think they have to have some special skills to survive at such a fast-paced environment?
DZ: Good question. I would say that we share several qualities such as commitment, common sense, the ability to work as a team, continuous improvement, … etc. We are consistent and committed to our work to give each day the best of us… Did I sell it well?… Hahaha… Jokes aside, in MedSIR there is a fantastic team with great potential. All these qualities help us to live better within a sector where the pace is quite high.
When we seek talent in MedSIR, we obviously value training and experience, but we also want it to be aligned with our values, and to share our company philosophy where each one is organized and planned in order to achieve their own and company objectives.
MS: If one thing distinguishes us from many other companies, it is the possibility to organize our working day as we want and be able to work from home. Yes, without ever losing sight of our objectives. How do you personally value this feature of MedSIR? Could you work in another company that does not share this philosophy?
DZ: Currently, I think that the model is changing and more companies are betting on a flexible schedule, but I think there is still a long way to go. In the case of MedSIR, from the beginning, there has always been the possibility of organizing your own working day. In this sense, I must say that family conciliation exists and is possible in a company like this.
The truth is that right now I would find it difficult to work in another different model of organization, having a strict office schedule.
In addition, I believe that MedSIR has adapted to the new environment, where it is important to have good working conditions that allow you to reconcile your free time, your family needs and your professional life. It is a challenge to be able to retain the best professionals and be able to demonstrate that we are an attractive enough company.
MS: And what about your hobbies? How do you keep yourself busy when not at MedSIR?
DZ: The activities that help me to disconnect from work are yoga and furniture restoration, but I have neglected them a bit because now I prefer to dedicate my free time to my two small children… and time just flies by!
Also, what really makes me completely disconnect is to escape the city on weekends(I think I’m too urban), and go to the beach or the mountain. It helps me to recharge batteries!
MS: Thanks so much Duna for your time
Thank you for these questions, and for highlighting some great elements of our company and the great team that we have at MedSIR.