IBCC / Research

Microscopic details of healthy mammary cells.

Microscopic details of cancerous cells.

Research

At the IBCC, we lead multiple national and international studies and clinical trials aimed at improving the diagnosis and treatment of breast cancer. From our Clinical Research Unit and Clinical Trials, we work intensively to achieve the following objectives:

1. Conduct clinical studies on breast cancer patients in all stages of development (I-IV), establishing the unit as a national and international reference center for clinical trial development.

2. Facilitate access to innovative drugs with significant therapeutic potential for our breast cancer patients.

3. Provide breast cancer patients with the opportunity to receive treatments not covered by their insurance, avoiding referrals to Public Health Hospitals.

4. Promote the establishment of a biological registry (biobank and serum bank) with the aim of participating in national and international translational research projects focused on breast cancer.

5. Increase the acquisition of breast cancer research projects and facilitate the transfer of clinical research project results into clinical practice, promoting innovation and healthcare quality.

6. Boost the publication of articles in high-impact scientific journals to increase the visibility of the center.

Active clinical trials

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

Our patients have the opportunity to participate in these trials, through 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 further increase cure rates.

TRIPLE NEGATIVE BREAST CANCER
ADYUVANT	A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)	Phase III	LINK
METASTASIC	Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer (ASCENT-03)	Phase III	LINK
	Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer (ASCENT-04)	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
	Phase II Study for PIK3CA/PTEN-altered Advanced Metaplastic Breast Cancer Treated With MEN1611 Monotherapy or in Combination With Eribulin (SABINA)	Phase II	LINK
	A Multicenter, Single-arm, Three Cohort, Phase II Trial Of Patritumab Deruxtecan (Her3-dxd) In Patients With Active Brain Metastases From Metastatic Breast Cancer And Non–Small Cell Lung Cancer, And In Patients With Leptomeningeal Carcinomatosis From Advanced Solid Tumors (The TUXEDO-3 Study)	Phase II	LINK

HER2-POSITIVE BREAST CANCER
METASTASIC	A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer (WO44263 Inavo122)	Phase III	LINK
	A Multicenter, Single-arm, Three Cohort, Phase II Trial Of Patritumab Deruxtecan (Her3-dxd) In Patients With Active Brain Metastases From Metastatic Breast Cancer And Non–Small Cell Lung Cancer, And In Patients With Leptomeningeal Carcinomatosis From Advanced Solid Tumors (The TUXEDO-3 Study)	Phase II	LINK

LUMINAL BREAST CANCER
NEOADJUVANT	Preoperative Window of Opportunity Study With Giredestrant (GDC-9545) or Tamoxifen in Premenopausal Women With Estrogen Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative & Ki67≥10% Early Breast Cancer (EMPRESS)	Phase II	LINK
ADJUVANT	A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer (EMBER-4)	Phase III	LINK
	A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients With ER+/HER2- Early Breast Cancer (CAMBRIA-1)	Phase III	LINK
METASTASIC	Study of ARV-471 (PF-07850327) Plus Palbociclib Versus Letrozole Plus Palbociclib in Participants With Estrogen Receptor Positive, Human Epidermal Growth Factor Negative Advanced Breast Cancer (VERITAC-3)	Phase III	LINK
	Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype (HARMONIA)	Phase II	LINK
	A Phase 1b Trial of ARV-471 in Combination with Everolimus in Patients with ER+, HER2– Advanced or Metastatic Breast Cancer	Phase I	LINK
	A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)	Phase III	LINK
	A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With The Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer)	Phase III	LINK
	TACTIVE-U: An interventional safety and efficacy Phase 1b/2, open-label umbrella study to investigate tolerability, pk, and antitumor activity of vepdegestrant (ARV-471/PF-07850327), an oral Proteolysis Targeting Chimera, in combination with other anticancer treatments in participants Aged 18 years and Over with ER+ advanced or Metastatic breast cancer, Sub-study A (ARV-471 in combination with Abemaciclib)	Phase 1b/2	LINK
	TACTIVE-U: An interventional safety and efficacy Phase 1b/2, open-label umbrella study to investigate tolerability, pk, and antitumor activity of vepdegestrant (ARV-471/PF-07850327), an oral Proteolysis Targeting Chimera, in combination with other anticancer treatments in participants Aged 18 years and Over with ER+ advanced or Metastatic breast cancer, Sub-study B (ARV-471 in combination with Ribociclib)	Phase 1b/2	LINK
	Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy (ASCENT-07)	Phase III	LINK
	Phase II Study for PIK3CA/PTEN-altered Advanced Metaplastic Breast Cancer Treated With MEN1611 Monotherapy or in Combination With Eribulin (SABINA)	Phase II	LINK
	A Multicenter, Single-arm, Three Cohort, Phase II Trial Of Patritumab Deruxtecan (Her3-dxd) In Patients With Active Brain Metastases From Metastatic Breast Cancer And Non–Small Cell Lung Cancer, And In Patients With Leptomeningeal Carcinomatosis From Advanced Solid Tumors (The TUXEDO-3 Study)	Phase II	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
	A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies (CERTIS1)	Phase I/II	LINK

Personalized treatment

Breast cancer is a generic term referring to various malignant diseases affecting the breast. In recent years, we have learned that each tumor has specific and distinct characteristics.

There is no single type of tumor, but rather many types, and moreover, each patient is unique. To achieve the best results in breast cancer treatment, it is necessary to design a truly personalized therapeutic plan tailored to each patient.

Understanding the molecular biology of breast cancer is emerging as a key factor in the discovery and application of new treatments at the clinical level, enabling increasingly personalized treatments and improving therapeutic options for patients.

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

The luminal subtype is the most common and includes tumors that express hormonal receptors, with luminal A tumors being more indolent and luminal B tumors being more aggressive. The HER2-enriched subtype is characterized by high expression of the oncogene encoding the HER2 receptor. The basal subtype usually corresponds to triple-negative tumors that do not express hormonal receptors or the HER2 receptor.

Furthermore, each subtype of breast cancer has been dissected specifically and in detail by The Cancer Genome Atlas (TCGA) project, allowing for the molecular portrait of each tumor to be available. All of this has led to the approval of several targeted treatments for breast cancer in recent years, substantially improving the prognosis of each breast cancer subtype.

At IBCC, we have access to the most advanced molecular diagnostic techniques, which generally include the following types of studies:

Molecular studies of the tumor:

These studies can be conducted directly on the patient’s tumor tissue or through a blood sample, known as liquid biopsy. In both cases, the presence of molecular alterations critical for tumor growth and development is analyzed, enabling access to new targeted treatments or participation in clinical trials with innovative therapies.

Genetic studies:

These studies can be carried out using a blood sample or a saliva sample; they are never performed on tumor tissue. The aim of these studies is to detect the presence of genes, which can be hereditary within a family, and significantly increase the risk of developing breast cancer and other types of tumors, particularly ovarian cancer. Detecting these genetic alterations allows for a more personalized follow-up for these patients, and offering preventive surgeries, both for the breasts and ovaries, with the aim of reducing the risk of developing cancer in both locations.

To carry out these studies, IBCC establishes strategic alliances, among which the one with Pangaea Oncology stands out. Pangaea Oncology is 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.