scholarly journals Safety and immunogenicity of neoadjuvant treatment using WT1-immunotherapeutic in combination with standard therapy in patients with WT1-positive Stage II/III breast cancer: a randomized Phase I study

2017 ◽  
Vol 162 (3) ◽  
pp. 479-488 ◽  
Author(s):  
M. Higgins ◽  
G. Curigliano ◽  
V. Dieras ◽  
S. Kuemmel ◽  
G. Kunz ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Phase I ◽  
Standard Therapy ◽  
Phase I Study ◽  
Neoadjuvant Treatment ◽  
Stage Ii

A phase I study of MM-302, a HER2-targeted liposomal doxorubicin, in patients with advanced, HER2-positive (HER2+) breast cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS663-TPS663 ◽  
Author(s):  
Pamela N. Munster ◽  
Kathy Miller ◽  
Ian E. Krop ◽  
Navreet Dhindsa ◽  
Joe Reynolds ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Phase I ◽  
Tumor Cells ◽  
Dose Escalation ◽  
Standard Therapy ◽  
Phase I Study ◽  
Liposomal Doxorubicin ◽  
Her2 Positive ◽  
Her 2

TPS663 Background: Anthracyclines have been an effective backbone of breast cancer therapies for decades. However, cardiotoxicity issues associated with free anthracyclines have limited their effective use in the clinic and led to the exploration of anthracycline-free regimens, particularly with HER2-positive cancers that require treatment with another cardiotoxic agent, trastuzumab. While liposomal doxorubicin formulations have succeeded in reducing cardiotoxicity, they have failed to demonstrate clear-cut efficacy advantages and can involve other toxicities. To address the safety and efficacy limitations of currently available anthracyclines, we have designed a new liposomal formulation, MM-302, that targets doxorubicin to HER2-overexpressing tumor cells. Antibody fragments that bind to HER2 without blocking HER2-mediated signaling are coupled to the outer surface of pegylated liposomal doxorubicin. MM-302 specifically binds and enters tumor cells overexpressing HER2 with minimal uptake into normal cells such as cardiomyocytes which express low levels of HER2. This first-in-human phase I study evaluates the safety of MM-302 in patients and provides preliminary efficacy data in HER-2+ advanced breast cancer (ABC). Methods: Patients aged > 18 years with histologically confirmed HER-2+ advanced breast cancer that have progressed or recurred on standard therapy or for which no standard therapy exists who have adequate performance status, bone marrow reserve, and organ function, are eligible for the study. Following a standard 3 + 3 dose escalation design, the maximum tolerated dose (MTD) or maximum feasible dose (MFD) is determined and up to 25 additional patients with HER-2+ ABC will be enrolled for a planned total of 40-49 patients. The primary endpoint is determination of the MTD/MFD. Secondary endpoints include determination of dose-limiting toxicity, adverse event(s), and pharmacokinetic and immunogenicity profiles of MM-302, as well as overall response and clinical benefit rates of MM-302. MM-302 is administered intravenously weekly in 4-week cycles. At the time of this submission, 8 patients have been enrolled in the dose escalation portion.

A Phase I Study of Neoadjuvant Chemotherapy With Nab-Paclitaxel, Doxorubicin, and Cyclophosphamide in Patients With Stage II to III Breast Cancer

2017 ◽  
Vol 17 (7) ◽  
pp. 503-509 ◽  
Author(s):  
Theresa L. Werner ◽  
Abhijit Ray ◽  
John G. Lamb ◽  
Matthew VanBrocklin ◽  
Kristin Hueftle ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Phase I ◽  
Phase I Study ◽  
Stage Ii

scholarly journals A Phase I Study of Pemetrexed (ALIMTA) and Cyclophosphamide in Patients with Locally Advanced or Metastatic Breast Cancer

2006 ◽  
Vol 12 (23) ◽  
pp. 7071-7078 ◽  
Author(s):  
Christian Dittrich ◽  
Lubos Petruzelka ◽  
Pavel Vodvarka ◽  
Margit Gneist ◽  
Filip Janku ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Phase I ◽  
Phase I Study ◽  
Locally Advanced ◽  
Metastatic Breast

scholarly journals Phase I Study of Panobinostat (LBH589) and Letrozole in Postmenopausal Metastatic Breast Cancer Patients

2016 ◽  
Vol 16 (2) ◽  
pp. 82-86 ◽  
Author(s):  
Winston W. Tan ◽  
Jacob B. Allred ◽  
Alvaro Moreno-Aspitia ◽  
Donald W. Northfelt ◽  
James N. Ingle ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Phase I ◽  
Cancer Patients ◽  
Phase I Study ◽  
Metastatic Breast ◽  
Breast Cancer Patients

Efficacy and safety of neoadjuvant docetaxel, carboplatin, trastuzumab, and pertuzumab (TCH-P) in HER2-positive breast cancer: An Indian experience.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e12619-e12619
Author(s):  
Ajay Gogia ◽  
Shalabh Arora ◽  
SVS Deo ◽  
Sandeep Mathur ◽  
Dayanand Sharma
Keyword(s):  
Breast Cancer ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Breast Conservation ◽  
Radical Mastectomy ◽  
Stage Ii ◽  
Breast Conservation Surgery ◽  
Secondary Outcome ◽  
Her2 Positive ◽  
Positive Breast Cancer

e12619 Background: Dual targeted therapy with chemotherapy is one of the therapeutic approaches as neoadjuvant treatment in HER2/neu positive breast cancer (BC). However the safety and efficacy data of dual-targeted, chemotherapy regimen (docetaxel, carboplatin, trastuzumab, & pertuzumab [TCH-P] is limited from the Indian subcontinent. Methods: This retrospective study aims to evaluate the efficacy and toxicity of neoadjuvant TCH-P regimen in early, locally advanced, and oligometastatic (OM) HER2-positive BC, at All India Institute of Medical Sciences, New Delhi, India, in between the period 2015-2020. Total 6 cycles of 3-weekly neoadjuvant chemotherapy (NACT) protocol containing docetaxel (75 mg/m2), carboplatin (AUC = 6), trastuzumab (8 mg/kg loading followed by 6 mg/kg) and pertuzumab ( 840 mg loading followed by 420 mg) were planned. Subcutaneous peg-filgrastim was prophylactically administered on day 2 of each cycle. The primary outcome was the pathological complete response (pCR), which was defined as an absence of invasive and noninvasive cancer in breast or lymph node and secondary outcome were clinical overall response rate (ORR), rate of breast conservation surgery( BCS) for patients for whom modified radical mastectomy( MRM)was planned and toxicity. Results: Forty-five patients with a median age of 48 years (31-65) were included in this study. The TNM (AJCC-7th edition) stage distribution was stage II, 14 (31.1%); stage III, 29 (64.5%); and stage IV (OM), 2 (4.4%). Clinical node positivity disease was found in 26 (57.8%) cases. Nineteen (42.2%) patients had hormone-positive and 26(57.8%) cases were premenopausal. The clinically ORR and CR were seen in 100% and 60% respectively. Overall pCR rate was observed in 25 (55.6%) patients (70% in stage II). BCS was performed in 23(51.1%) cases. In 12(26.6%) cases, planned MRM was changed to BCS following NACT. Grade 3 and 4 toxicities were diarrhea 7 cases, thrombocytopenia in 6, neutropenia in 4, febrile neutropenia in 1, and anemia in 2 cases. Ten patients required dose modification and interruption. No patient had congestive heart failure or induction death. Conclusions: This is the first study of the non-anthracycline-based neoadjuvant protocol in HER2 positive BC from India. The TCH-P is an effective, safe, and well-tolerated, protocol with a path CR rate of 55.6% and 26.6% BCS conversion rate from planned MRM.

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