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
METASTASIC	An Open-label Randomised, Phase II Trial of Datopotamab Deruxtecan Plus Durvalumab Versus Datopotamab Deruxtecan in Patients With PDL1-negative Metastatic Triple-negative Breast Cancer (DIAMOND)	Phase II	LINK
	A Phase III, Multisite, Randomized, Double-Blind Trial of BNT327 in Combination With Chemotherapy Versus Placebo With Chemotherapy in Patients With Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC Determined Ineligible for PD(L)1 Therapy Based on PD-L1 Negative Disease (ROSETTA BREAST 01)	Phase III	LINK
	Phase Ib/II Study to Evaluate Safety and Preliminary Efficacy of the Wee1 Inhibitor Debio 0123 in Combination With Sacituzumab Govitecan in Triple-negative or HR+/HER2- Advanced/ Metastatic Breast Cancer	Phase Ib/II	LINK

HER2-POSITIVE BREAST CANCER
NEOADJUVANT	A randomized, open-label, phase II trial comparing neoadjuvant endocrine therapy in combination with trastuzumab, pertuzumab +/- the PI3K inhibitor inavolisib in patients with HER2-positive, HR-positive, PIK3CA mutant early breast cancer- GeparPiPPa	Phase III	LINK
ADJUVANT	A Randomized, Multicenter, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects With Residual Disease or High-Risk PCR After Both Neoadjuvant and Postoperative Adjuvant Trastuzumab-based Therapy (FLAMINGO-01)	Phase III	LINK
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

LUMINAL BREAST CANCER
NEOADJUVANT	Phase II, multicenter, randomized, open-label study of premenopausal women with luminal breast cancer investigating the effect of oral SERD elacestrant with/without triptorelin in the ER functional pathway and Ki67 proliferation. Preoperative trial – PremiÈRe	Phase II	EUDRACT: 2023-503373-37-00
ADJUVANT	Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT)	Phase III	LINK
	A Proof of Concept Study to Evaluate Treatments’ Efficacy by Monitoring Minimal Residual Disease Using ctDNA in HR-positive/HER2-negative Early Breast Cancer Population (MIRADOR)	Phase II	LINK
METASTASIC	A Randomized Phase II Study to Evaluate the Safety and Efficacy of Trastuzumab Deruxtecan Versus CDK4/6 Inhibitor-based Endocrine Therapy as First-line Therapy of HR-positive and HER2-low/Ultralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype According to Gene Expression Profiling (PONTIAC)	Phase III	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 Randomized Phase 3, Double-Blind, Placebo-Controlled Study of Elacestrant Plus Everolimus Versus Elacestrant in Patients With ER+/HER2-, ESR1mut Advanced Breast Cancer Progressing to Endocrine Therapy and CDK4/6 Inhibitors (ADELA)	Phase III	LINK
	First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors (PIKALO 01)	Phase I	LINK
	A Phase 3 Randomized, Double-Blind, Active-Controlled Study of Palazestrant with Ribociclib Versus Letrozole with Ribociclib for the First-Line Treatment of ER+, HER2– Advanced Breast Cancer (OPERA-02)	Phase III	LINK
	Phase II Study to Evaluate the Efficacy and Safety of Camizestrant Plus Ribociclib in Patients With Hormone Receptor Positive (HR+) Breast Cancer (CADILLAC)	Phase II	LINK

ALL SUBTYPES
METASTASIC
	A Phase 2 open-label basket study to evaluate the efficacy and safety of orally administered reversible tyrosine kinase inhibitor BAY 2927088 in participants with metastatic or unresectable solid tumors with HER2-activating mutations (Pan SOHO)	Phase II	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
	A Phase 1/2, Open-label, Multicenter, Dose-escalation, and Dose-Optimization Study to Evaluate the Safety, Tolerability, and Activity of EIK1004 (IMP1707) as Monotherapy in Participants With Advanced Solid Tumors	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.