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ENSAYOS CLÍNICOS EN TUMORES TRIPLE NEGATIVO
 ONGOING STUDIES
AZD2281 (PARP INHIB.) [NEOADY..]
Ensayo fase I/II, abierto, multicéntrico, de AZD2281 oral en combinación con Cisplatino, para valorar la seguridad y tolerabilidad en pacientes con tumores sólidos avanzados, y para valorar la eficacia como terapia neoadyuvante en pacientes con cáncer de mama triple negativo.
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SOLTINEOPARP (TCD11419) [NEOADY.]
Randomized, open-label, phase 2 study of the efficacy and safety of weekly paclitaxel single-agent and two different regimens of the PARP-1 inhibitor SAR240550 (BSI-201) in combination with weekly paclitaxel, as neoadjuvant therapy in patients with Stage II-IIIA triple negative breast cancer (TNBC)
ClinicalTrials.gov Identifier: NCT01204125
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FOLLOW-UP STUDIES
BEATRICE [ADYUV.]
An international multi-centre open-label 2-arm phase III trial of adjuvant bevacizumab in triple negative breast cancer.
ClinicalTrials.gov Identifier: NCT00528567
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CAPRICE [NEOADY.]
A phase II multicentre open label study of liposomal doxorubicin (Caelyx®) as PRImary treatment in patients with previous Cardiac disease or Elderly (> 65 years).
ClinicalTrials.gov Identifier: NCT00563953
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CLOSED
BALI-1 [1ª-2ª LÍNEA]
Randomized phase II trial with Cetuximab and cisplatin in the treatment of metastatic ER-negative, PR-negative, HER-2 negative metastatic breast carcinoma (“triple negative”).
ClinicalTrials.gov Identifier: NCT00463788
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ENSAYOS CLÍNICOS EN TUMORES HER2/ERBB2
ONGOING STUDIES
NERATINIB (HKI-272) [1ª LÍNEA]
A phase III, randomized, open-label, two-arm study of neratinib plus paclitaxel vs trastuzumab plus paclitaxel as 1st line for ErbB2-positive locally recurrent or metastatic BNC.
ClinicalTrials.gov Identifier: NCT00915018
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FOLLOW-UP STUDIES
ALTTO [ADYUV.]
Adjuvant Pivotal Trial of HeRceptin or Lapatinib or Dual InhibiTion of ErbB2 in patients with breast cancer. (ALTTO Study).
ClinicalTrials.gov Identifier: NCT00490139
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HERA [ADJUV.]
Estudio multicéntrico, randomizado, de tres brazos, comparando la administración de Herceptin® durante uno y durante dos años versus la no-administración de Herceptin® en mujeres con cáncer de mama primario HER2- positivo que han completado la quimioterapia adyuvante.
ClinicalTrials.gov Identifier: NCT00045032
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MYOCET TRIAL FASE III [1ª LÍNEA]
Ensayo en fase III, aleatorizado y controlado de Myocet, trastuzumab y paclitaxel frente a trastuzumab y paclitaxel para el tratamiento de primera línea del cáncer de mama metastásico.
ClinicalTrials.gov Identifier: NCT00294996
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NEO-ALTTO [NEOADY.]
A Randomized, Multicenter Open-Label Phase III Study of Neoadjuvant lapatinib, trastuzumab and their combination plus paclitaxel in women with HER2/ErbB2 positive primary breast cancer. (Neo-ALTTO Study).
ClinicalTrials.gov Identifier: NCT00553358
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NOAH [NEOADY.]
Neoadjuvant trastuzumab in patients with HER2-positive locally advanced breast cancer: a randomized phase III trial with a parallel HER2-negative cohort.
ClinicalTrials.gov Identifier: ISRCTN86043495
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STUDIES IN TRAMITATION
APHINITY (BIG-04-11/ BO25126/ TOC4939G) [ADYUV]
A prospective, randomized multicenter, multinational, double-blind placebo controlled comparison of chemotherapy plus trastuzumab and placebo given for a total of one year versus chemotherapy plus trastuzumab and pertuzumab given for a total of one year as adjuvant therapy in patients with operable HER2-positive primary breast cancer.
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CLOSED
MYOCET TRIAL FASE II [1ª LÍNEA]
A Phase II Randomized, Controlled Trial of Myocet, Trastuzumab and Paclitaxel versus Trastuzumab and Paclitaxel for first line therapy of Metastasic Breast Cancer.
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WO17299 [1ª LÍNEA]
Estudio de fase II de Herceptin®, solo o en combinación con una taxano, como tratamiento de primera línea para pacientes con cáncer de mama metastásica que han recaído tras recibir Herceptin durante el periodo adyuvante para el cáncer de mama primario HER positivo.
ClinicalTrials.gov Identifier: NCT00475670
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ENSAYOS CLÍNICOS EN TUMORES CON RRHH POSITIVOS
ONGOING STUDIES
CA180P52 DASATINIB/EXEMESTANE [RECURRENTE]
Randomized double-blind Phase II trial of exemestane (Aromasin®) plus dasatinib vs exemestane plus placebo in advanced ER+ breast cancer after disease progression on a non-steroidal aromatase inhibitor (NSAI).
ClinicalTrials.gov Identifier: NCT00767520
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SOLE [ADYUV.]
A phase III trial evaluating the role of continuous letrozole versus intermittent letrozole following 4 to 6 years of prior adjuvant endocrine theraphy for postmenopausal women with hormone-receptor positive, node positive early stage breast cancer.
ClinicalTrials.gov Identifier: NCT00553410
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FOLLOW-UP STUDIES
BOLERO 2 [LABC/MBC]
A randomized Double-Blind, Placebo-Controlled Study of Everolimus in Combination with Exemestane in the Treatment of Postmenopausal Women with Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer who are refractory to Letrozole or Anastrozole.
ClinicalTrials.gov Identifier: NCT00863655
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SOFT (IBCSG) [ADYUV.]
A Phase III Trial Evaluating the Role of the Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women with Endocrine Responsive Breast Cancer.
Subestudio SOFT-EST (SOLTI-0801)[ADYUV.]. SOFT sub-study which investigates estrogen suppression for patients participating in the SOFT trial and randomized to arms B and C.
Subestudio CO-SOFT SOFT sub-study which investigate cognitive functions for patients participating in the SOFT trial in selected centers.
ClinicalTrials.gov Identifier: NCT00066690
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STUDIES IN TRAMITATION
MK-0646 [NEOADY. ]
A phase II randomized, open-label clinical trial of neoadjuvant letrozole combined with MK-0646 versus letrozole alone in post-menopausal women with ER-positive/HER2-negative primary breast cancer.
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CLOSED
EVEROLIMUS [NEOADY.]
Phase II Randomized Study of Neoadjuvant Everolimus Plus Letrozole Compared with Placebo Plus Letrozole in Patients with Estrogen Receptor-Positive Breast Cancer.
ClinicalTrials.gov Identifier: NCT00107016
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ENSAYOS CLÍNICOS EN ENFERMEDAD RECURRENTE, LOCALMENTE AVANZADA O METASTÁSICA
ONGOING STUDIES
RESILIENCE - SORAFENIB PHASE III (BAY 43-9006) [1-2 LINE]
A Phase III Randomized, Double‑blind, Placebo-controlled Trial Comparing Capecitabine Plus Sorafenib Versus Capecitabine Plus Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer
ClinicalTrials.gov Identifier: NTC01234337
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FOLLOW-UP STUDIES
THYME AZD8931 (EGFR TIROSYN KINASES INHIB.) [NO TAXANOS]
A phase I/II multi-centre study of AZD8931 in combination with weekly paclytaxel to assess the safety, tolerability, pharmacokinetics and efficacy in patients with advanced solid tumours and in a selected population with low HER2-expressing locally recurrent and/or metastasic breast cancer.
ClinicalTrials.gov Identifier: NCT00900627
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CLOSED
CAPE-GEM (SOLTI0301) [TRATADOS CON ANTRACICLINAS]
Estudio fase II de la combinación Gemcitabina y Capecitabina en el tratamiento de pacientes con cáncer de mama avanzado previamente tratadas con antraciclinas.
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SOLTI 0701 [1ª-2ª LÍNEA]
A double blind, randomized phase 2b study evaluating the efficacy and safety of sorafenib compared to placebo when administered in combination with capecitabine in patients with locally advanced or metastatic breast cancer.
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ESTUDIOS ACADÉMICOS INTERGRUPOS QUE PRETENDEN CONTESTAR PREGUNTAS DE ALTA TRASCENDENCIA CLÍNICA
ONGOING STUDIES
MINDACT [ADYUV.]
AEstudio prospectivo, aleatorizaodo que compara la firma de expresión de 70 genes de Amsterdam (firma de 70 genes) con los criterios clínico-patológicos comúnmente utilizados en la selección de pacientes con cáncer de mama de 0 a 3 ganglios positivos para quimioterapia adyuvante.
ClinicalTrials.gov Identifier: NCT00433589
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FOLLOW-UP STUDIES
AZURE [NEOADY./ ADYUV.]
Ensayo Clínico para determinar si el ácido zoledrónico proporciona beneficios adicionales a los de la quimioterapia y/o terapia hormonal en el tratamiento de mujeres con cáncer de mama.
ClinicalTrials.gov Identifier: NCT00072020
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ECTO II [NEOADY.]
European Cooperative Study of Primary Systemic Therapy in Women with Operable Breast Cancer and T > 2 cm.
ClinicalTrials.gov Identifier: ISRCTN96423607
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STUDIES IN TRAMITATION
BIG 02-07 MALE BREAST CANCER [REGISTRO PROSPECTIVO]
International registration and biologic characterization programme.
ClinicalTrials.gov Identifier: NCT01101425
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