Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Carcinoma

Breast Neoplasms

Triple Negative Breast Neoplasms

Pathologic Complete Response

Neoplasm, Residual

Breast Diseases

Skin Diseases

Neoplastic Processes

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Carboplatin

Cyclophosphamide

Busulfan

Carmustine

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Patients will receive a high dose chemotherapy regimen, consisting in the administration of three medications: Carmustine (BCNU) 300mg/m2 or Busulfan 16 mg/kg (according to availability), Cyclophosphamide 80mg/kg, and Carboplatin 1400/m2.

Then they will undergo an Autologous Hematopoietic Stem Cell Transplantation.

80mg/kg, IV, in 2 hours, during two days -2, -3

Autologous Hematopoietic Stem Cell Transplantation

Eucario Leon Rodriguez, M.D.

Monica M Rivera Franco, M.D.,MSc

Monica M Rivera Franco, M.D.

Alejandra Armengol Alonso, M.D.

Triple-negative breast cancer (TNBC) refers to any breast cancer that does not express estrogen receptor (ER), progesterone receptor (PR) or Her2/neu. Its incidence is approximately 180,000 cases per year. TNBC are known to be more aggressive with poor prognosis specially when no pathologic complete response (pCR) is achieved after neoadjuvant chemotherapy, with a higher risk of recurrence and a poor survival once that recurrence occurs. On the other hand, there is not a specific adjuvant or neoadjuvant treatment for these patients. Since autologous hematopoietic stem cell transplantation (HSCT) allows the usage of higher doses of chemotherapy, which results in higher cellular destruction with a decrease of hematological toxicity, it is proposed that this procedure is able to improve prognosis in TNBC patients with no pathologic complete response after neoadjuvant chemotherapy.

Triple-negative breast cancer (TNBC) accounts for approximately 15%-25% of all breast cancer cases. TNBC are usually high-grade tumors, presented among younger women, African American and Hispanic women have a higher risk; generally in advanced stages when diagnosed, with visceral recurrence (liver, lung, brain). Standard treatment is surgery with adjuvant chemotherapy and radiotherapy. As a variation, neoadjuvant chemotherapy is very frequently used for triple-negative breast cancers, however, there is a lack of specific agents for this subset of patients, and, pathologic complete response does correlate with overall survival. At the moment, no optimal chemotherapy exists for TNBC patients who do not achieve a pCR.

According to the German group, in the triple negative subset, 31% of patients with neoadjuvant chemotherapy achieved pathologic complete response (pCR), which correlates with progression free survival (HR 6.02 for those who do not achieve pCR), and an overall survival (HR 12.41 for those who do not achieve pCR).

The usage of high-dose chemotherapy with autologous HSCT, is one of the therapies that have been studied in the patients with localized breast cancer aiming to improve its outcome. Autologous HSCT allows higher chemotherapy doses, which results in higher tumor cells destruction. Since 1980, several phase II studies were performed with high-dose chemotherapy and autologous HSCT, with an apparently initial benefit, thus this strategy was widely used outside controlled clinical trials. Afterward, the randomized studies did not show benefit in overall survival, causing this strategy to be abandoned.

It is important to highlight studies heterogeneity by means of different treatment options in both experimental and control group, besides, advances in autologous HSCT has significantly reduced the complexity, mobility, and mortality related to the chemotherapy treatment.

Two published studies including patients with localized TNBC, showed benefit in the progression free survival in the high-dose chemotherapy group, with a tendency to improved overall survival. One of them was performed by a german group, including patients with at least 9 positive nodes, which were randomized to receive two cycles of conventional dose chemotherapy followed by two cycles of high-dose chemotherapy with autologous HSCT versus four cycles of conventional dose chemotherapy followed by three cycles of dense dose chemotherapy, with granulocyte colony-stimulating factor (G-CSF) administration. Progression free survival was 76 months in the group of high dose chemotherapy versus 40.6 months in the conventional chemotherapy group, with an overall survival of 60 versus 44%, being statistically significant.

Our hypothesis is that patients with TNBC with a high risk of recurrence (no pCR) who undergo high-dose chemotherapy followed by autologous HSCT will have a higher overall survival compared to those who do not undergo the above mentioned treatment.

Autologous Hematopoietic Stem Cell Transplantation as Adjuvant Treatment for Triple Negative Breast Cancer Patients

High-dose Chemotherapy With Autologous Hematopoietic Stem Cell Transplantation as Adjuvant Treatment for Triple Negative Breast Cancer Patients Without Complete Pathological Response to Neoadjuvant Chemotherapy

Time from diagnosis to death from any cause.

Time from ending primary treatment to relapse of the disease.

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

Patients in whom primary cytoreduction was performed using a laparoscopic approach

Patients in whom primary cytoreduction was performed using an open abdominal approach

Primary cytoreduction for ovarian cancer performed through a completely minimally-invasive approach

Laparoscopic primary cytoreduction

Stefano Uccella, MD, PhD

To assess the feasibility, Residual Tumor, complication rate and survival of totally laparoscopic primary cytoreduction in carefully selected patients with Advanced Ovarian Cancer, compared with abdominal primary cytoreduction in a single-Institution, single-surgeon prospective series.

All patients with presumed stage III-IV ovarian cancer and clinical conditions allowing aggressive surgery were candidate to possible primary cytoreduction with the aim of achieving residual tumor=0. A definite protocol was adopted: after radiological preoperative evaluation with PET-CT scan, all patients underwent laparoscopic evaluation with the Fagotti score. Once considered suitable for primary debulking surgery, the possibility of attempting laparoscopic cytoreduction was carefully evaluated using strict selection criteria; patients were divided in two groups, based on the type of surgical approach. At the end of laparoscopic primary cytoreduction, a ultra-low pubic minilaparotomy was performed to extract surgical specimens and to perform laparoscopic hand-assisted exploration of the abdominal organs, in order to ensure complete excision of the disease. Surgical data, optimal cytoreduction (defined as residual tumor=0) rates and survival outcomes were investigated.

Laparoscopy for Primary Cytoreductive Surgery in Advanced Ovarian Cancer

Laparoscopy for Primary Cytoreductive Surgery in Advanced Ovarian Cancer: a Prospective Validation and Comparison With Open Surgery.

Università degli Studi dell'Insubria

Doctor

Nervous System Diseases

Brain Neoplasms

Use of 3D ultrasound intraoperative before intraoperative MRI

no use of intraoperative ultrasound before intraoperative MRI

resection with help of 3D ultrasound

Jan Coburger, apl. Prof. Dr. med.

Christian R Wirtz, Prof. Dr. med.

Constantin Roder, Prof. Dr. me.d

Jan Coburger, MD

Evaluation of impact of use of 3D ultrasound in brain tumor surgery on extend of resection. Benefit for surgery, neurological outcome, accuracy and image quality are secondary outcome parameters. Control group is a retrospective matched pair cohort.

Evaluation of 3D Ultrasound in Brain Tumor Surgery

brainshift in mm during surgery comparing preoperative landmarks with intraoperative landmarks in ultrasound and intraooperative MRI

Volumetric assessment of residual T1 contrast enhancement or FLAIR signal changes in enhancing and non-enhancing glioma, respectively.

ultrasound image quality, both for 2D and 3D as rated by surgeon and scored from 1(best) to 6 (worst).

both at discharge and at 3 months follow up using NIHSS Score

ultrasound image acuracy compared to preoperative MRI, both for 2D and 3D as rated by surgeon and scored from 1(best) to 6 (worst), including rating of brainshift and navigation inaccuracy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Autologous Hematopoietic Stem Cell Transplantation as Adjuvant Treatment for Triple Negative Breast Cancer Patients	NCT02670109	Triple-Negative... Residual Tumor	Carmustine Cyclophosphamid... Carboplatin Autologous Hema... Busulfan	18 Years - 60 Years	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Laparoscopy for Primary Cytoreductive Surgery in Advanced Ovarian Cancer	NCT02980185	Residual Tumor Disease-free Su... Overall Surviva...	Laparoscopic pr...	-	Università degli Studi dell'Insubria
Evaluation of 3D Ultrasound in Brain Tumor Surgery	NCT05956977	Residual Tumor	resection with ...	18 Years -	University of Ulm

Spots Global Cancer Trial Database for residual tumor