IBCC / Research

MICROSCOPIC DETAIL OF HEALTHY BREAST CELLS

MICROSCOPIC DETAIL OF CANCER CELLS

Research

At the IBCC we lead multiple national and international studies and clinical trials for the improvement of the diagnosis and treatment of breast cancer. From our Clinical Research and Clinical Trial Unit we work intensively to achieve the following objectives:

1. To carry out clinical studies in patients with breast cancer in all its stages of development (I-IV), making the unit a leading national and international facility for the development of clinical trials.

2. To provide our breast cancer patients with access to innovative drugs with significant therapeutic potential.

3. To offer breast cancer patients the opportunity to receive treatments not covered by their insurers, avoiding referral to public hospitals.

4. To promote the creation of a biological registry (biobank and serum storage) with the aim of participating in national and international translational research projects focused on breast cancer.

5. To increase the acquisition of research projects in breast cancer, and facilitate the transfer of clinical research results to clinical practice, promoting innovation and quality of care.

6. To encourage the publication of articles in journals of high scientific impact and give visibility to the centre.

Active clinical trials

At the IBCC we lead international clinical trials and work with knowledge networks and prestigious scientific institutions to achieve the most effective treatments against breast cancer.

Our patients have the opportunity to participate in these trials, as a result of which new drugs and treatments have been developed. We work tirelessly to improve the survival and quality of life of all women with breast cancer, and to increase recovery rates even further.

TRIPLE-NEGATIVE BREAST CANCER
ADJUVANT	A Phase III, Multicenter, Randomized, Open-Label Study Comparing Atezolizumab (Anti PD-L1 Antibody) in Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone in Patients With Operable Triple Negative Breast Cancer	Phase III	LINK
	A Randomized Phase 3 Double-Blinded Study Comparing the Efficacy and Safety of Niraparib to Placebo in Participants With Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer With Molecular Disease Based on Presence of Circulating Tumor DNA After Definitive Therapy (ZEST)	Phase III	LINK
METASTATIC	A Multicenter, Open-Label, Non-Comparative, Three-Arm, Phase IIa Trial of Ipatasertib (GDC-0068) in Combination With Non-Taxane Chemotherapy Agents for Taxane-Pretreated Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer Patients (PATHFINDER)	Phase II	LINK
	A Phase 3, Randomized, Double-Blind Study of Trilaciclib or Placebo in Patients Receiving First- or Second-Line Gemcitabine and Carboplatin Chemotherapy for Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (PRESERVE 2)	Phase III	LINK
	A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02)	Phase III	LINK

HER2-POSITIVE BREAST CANCER
NEOADJUVANT	Chemotherapy-Free pCR-Guided Strategy With Subcutaneous Trastuzumab-pertuzumab and T-DM1 in HER2-positive Early Breast Cancer (PHERGAIN-2)	Phase II	LINK
ADJUVANT	A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Participants With High-Risk HER2-Positive Primary Breast Cancer Who Have Residual Invasive Disease in Breast or Axillary Lymph Nodes Following Neoadjuvant Therapy (DESTINY-Breast05)	Phase III	LINK
METASTASIC	A Phase II Trial of Palbociclib in Combination With Trastuzumab and Endocrine Therapy in Patients With Previously-treated Locally Advanced or Metastatic HER2-positive Breast Cancer (PATRICIA II)	Phase II	LINK
	Phase III Study of Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer (DESTINY-Breast09)	Phase III	LINK

LUMINAL BREAST CANCER
ADJUVANT	A Randomized Phase 3 Double-Blinded Study Comparing the Efficacy and Safety of Niraparib to Placebo in Participants With Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer With Molecular Disease Based on Presence of Circulating Tumor DNA After Definitive Therapy (ZEST).	Phase III	LINK
	A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Patients With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer	Phase III	LINK
METASTASIC	A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (PERSEVERA)	Phase III	LINK
	An International Multicenter Phase An International Multicenter Phase II Trial of Durvalumab (MEDI4736) Plus OLAparib Plus Fulvestrant in Metastatic or Locally Advanced ER-positive, HER2-negative Breast Cancer Patients Selected Using Criteria That Predict Sensitivity to Olaparib (DOLAF)	Phase II	LINK
	A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)	Phase III	LINK

ALL SUBTYPES
METASTASIC	A Phase 1b, Open-label, Parallel Group, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Oral Decitabine and Cedazuridine (ASTX727) in Cancer Patients With Moderate and Severe Hepatic Impairment	Phase I	LINK
	A Phase 1b, Open-label, Parallel Group, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Oral Decitabine and Cedazuridine (ASTX727) in Cancer Patients With Severe Renal Impairment and Cancer Patients With Normal Renal Function	Phase I	LINK

Personalized Treatment

Breast cancer is a generic term that refers to different malignant diseases that affect the breast. In recent years we have learned that each tumour has distinct and specific characteristics.

There is not one single type of tumour, but many types of tumours and, in addition, each patient is unique. To achieve the best results in the treatment of breast cancer, it is necessary to design a truly personalized therapeutic plan adapted to each patient.

Knowledge of the molecular biology of breast cancer is becoming a key factor for the discovery and application of new treatments at a clinical level, allowing more and more personalized treatments and improving the therapeutic options of patients.

Breast cancer is a heterogeneous disease with multiple clinical presentations which, thanks to gene expression studies, have been classified into four major subtypes: luminal A, luminal B, HER2-enriched and basal, which has led to a new molecular classification of breast cancer with both prognostic and therapeutic implications.

The luminal subtype is the most common and includes tumours that express hormone receptors, these being the more indolent luminal A tumours and the more aggressive luminal B ones; the HER2-enriched subtype is characterized by high expression of the oncogene that encodes the HER2 receptor; and the basal subtype tends to correspond to triple-negative tumours, which do not express either hormone receptors or the HER2 receptor.

Furthermore, each subtype of breast cancer has been dissected in a specific and detailed way by The Cancer Genome Atlas (TCGA) project, which has allowed the molecular portrait of each tumour to be made available. All of this has led to the approval of several targeted treatments for breast cancer in recent years which have substantially improved the prognosis of each of the breast cancer subtypes.

At the IBCC we have the most advanced molecular diagnostic techniques available which, in general terms, include the following types of studies:

Molecular tumour studies: These studies may be carried out directly on the patient’s tumour tissue, or by means of a blood sample, called a liquid biopsy. In both cases, the presence of molecular alterations which are critical for the growth and development of the tumour, and which allow access to new targeted treatments or participation in clinical studies with innovative therapies, are analyzed.

Genetic studies: These studies may be carried out using a blood sample or saliva sample; they are never performed on tumour tissue. The aim of these studies is to detect the presence of genes, which can be transmissible within the same family, and which significantly increase the risk of developing breast cancer and other types of tumours, especially ovarian cancer. The detection of these genetic alterations allows us to design a more personalized follow-up for these patients, and offer preventive surgeries, both of the breasts and of the ovaries, with the aim of reducing the risk of developing cancer in both locations.

In order to develop these studies, the IBCC forms strategic partnerships, most notably one established with the organization Pangaea Oncology, a leading medical services company, focused on precision oncology and personalized medicine based on genetic analysis to improve the survival and quality of life of cancer patients.