Active clinical trials for "Breast Neoplasms"

Neoadjuvant (preoperative) chemotherapy is an interesting research tool which allows investigators to test new drugs and/or new schedules with a validated surrogate endpoint, pCR. It also represents an ideal model to evaluate the relationships between treatments and tumor biomarkers. Recent publications have shown that new molecular classifications of breast cancer (intrinsic subtypes) have an important prognostic and predictive value. Using microarrays for gene expression profiling seems to be the best way to perform this classification; nevertheless such assays are not optimally available for common clinical practice. The IHC-based classification systems are still useful, as fresh tissue is not normally available in clinical practice, and has been shown to correlate well with intrinsic classification using gene expression microarrays. Recently the PAM50 gene set provided a risk of relapse score not only in ER-positive, node negative patients (similarly to the Oncotype Dx Recurrence Score) but also in the ER negative disease. Additionally, the PAM 50 assay was highly predictive of neoadjuvant response when considering all patients. This assay added significant prognostic and predictive value to pathologic staging, histologic grade, and standard clinical molecular markers while using an easy technique that can be performed in clinical practice because the qRT-PCR assay can be performed using FFEP tissue. Triple Negative Breast Cancer (TNBC) is defined by a lack of expression of ER, PgR and HER-2. DNA microarray profiling studies have led to the classification of invasive breast carcinoma into five subtypes: luminal A and B, normal breast-like, HER2/neu overexpressing and basal-like subtypes, with clinical implications. Later on, a new subtype, the claudin-low, has been described. Although not synonymous, the majority of TNBCs carry the basal-like breast cancer (BLBC) molecular profile. The triple negative subtype accounts for 11-20% of breast cancer in different studies, whereas in selected cohorts of patients with advanced breast cancer or African-American ethnicity, TNBC may be diagnosed among as many as 23-28%. Patients with TN breast tumors treated with standard chemotherapy have a shorter DFS and OS than non-TNBC, this difference have been shown to be independent from tumor grade, nodal status and treatment in some studies. The peak risk of recurrence occurs within the first 3 years after initial treatment, with the majority of deaths occurring in the first five years. Chemotherapy remains the only systemic treatment option available for TNBC patients. Several studies have shown that TNBC/BLBC is associated with an increased response rate to neoadjuvant chemotherapy when compared with luminal tumors. However, TNBC patients have a significantly decreased DFS and OS in comparison with luminal patients. The largest study exploring response and survival in early stage breast cancer treated with neoadjuvant chemotherapy was reported by Liedtke et al. Although an increase pCR rate was observed among the TNBC patients, they had a shorter lifespan than the non-TN ones. Patients experiencing pCR had an excellent OS regardless of hormone receptor expression, but patients with residual disease had a significantly shorter survival associated with TNBC compared with non-TN ones. This demonstrates that poor OS is derived from chemo-resistant patients (what unfortunately represent > 50% of them). A relevant problem is the differential response to drugs of TN tumors. These tumors are usually treated with multidrug combinations including anthracyclines and taxanes, with pCR´s of 28-32%. Only recently, the results of a few small trials combining platinum salts and taxanes have been reported, with encouraging results (pCR of 44-77%). The taxane-platinum salt combinations have a biological background, since TN not associated BRCA1 mutations are sensitive to taxanes and resistant to anthracyclines and platinum salts are effective in TN tumors probably because a significant proportion of them have functional DNA repair deficiencies. The primary objective of the study is to identify predictors of response to docetaxel-carboplatin in patients with triple negative primary tumors. Response is defined as lack of invasive tumor in breast plus axilla after neoadjuvant chemotherapy (PCR, pathological complete response).

This study will determine the highest dose of KW-2450 in combination with lapatinib and letrozole that can be administered safely to subjects with advanced or metastatic breast cancer and to evaluate its effectiveness. This study was terminated in Phase 1 and never proceeded to the Phase 2 portion of the study.

The purpose of this study is to determine whether Paclitaxel and bevacizumab showed improved PFS compared to paclitaxel alone. Recent results of the AVADO study report a similar result for the combination of docetaxel and bevacizumab. The AVADO study furthermore confirmed the dose of 15 mg/kg BW of bevacizumab. As in metastatic breast cancer (MBC) poly-chemotherapies are frequently used, regimens with bevacizumab and at least 2 cytotoxic agents should be investigated. Docetaxel and capecitabine showed a benefit in PFS and survival. This combi- nation is therefore a reasonable choice. Dose of capecitabine and docetaxel should be reduced to 1800 mg/m2 and 75 mg/m2 to improve tolerability without compromising efficacy. Paclitaxel and capecitabine is well tolerated and showed a PFS of 10.3 months. Docetaxel 100 mg/m2 as monotherapy in MBC not very often used b/o toxicity. 75 mg/m2 much more accepted in daily practice. Better comparability with DBX, if both arms have 75mg/m2 docetaxel as assumed.

AFP464 is an investigational agent which may be effective in the treatment of cancer. The purpose of this study is to test the efficacy of AFP464 +/- Faslodex in ER+ breast cancer patients.

This pilot clinical trial studies biomarkers in tissue samples from patients with newly diagnosed breast cancer treated with zoledronic acid (ZA). Studying samples of tumor tissue in the laboratory from patients receiving ZA may help doctors learn more about the effects of ZA on cells. It may also help doctors understand how well patients respond to treatment.

In this study, the investigators are testing the effectiveness of the combination of eribulin, pertuzumab and trastuzumab to learn whether this combination of drugs works in treating advanced HER2-positive breast cancer that had received at least one prior treatment previously. At this point, the standard treatment for HER2-positive cancer that has progressed (grown) after a first treatment is chemotherapy combined with therapies that target the HER2 protein (e.g., trastuzumab or lapatinib).

This phase II trial studies how well radiation therapy works in treating post-menopausal women with early stage breast cancer undergoing surgery. Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective treatment for breast cancer.

This research is being done to find out how safe and how well the combination of lapatinib and vorinostat works against advanced cancers.

This study will assess the safety and efficacy of BKM120 in combination with trastuzumab in patients with relapsing HER2 overexpressing breast cancer who have previously failed trastuzumab. The study will further assess the safety and preliminary efficacy of BKM120 in combination with trastuzumab and capecitabine in patients with relapsing HER2 overexpressing breast cancer and brain metastases (BM) who have previously failed trastuzumab.

This randomized pilot clinical trial studies rosuvastatin in treating women with cardiovascular complications who are undergoing chemotherapy for breast cancer. Rosuvastatin may prevent or lessen cardiovascular complications in patients undergoing chemotherapy for breast cancer