scholarly journals Swiss Group for Clinical Cancer Research (SAKK) – Breast Cancer Project Group

2006 ◽  
Vol 9 (S1) ◽  
pp. 419-429
Author(s):  
Keyword(s):  
Breast Cancer ◽  
Cancer Research ◽  
Clinical Trials ◽  
Metastatic Breast Cancer ◽  
Phase I ◽  
Advanced Breast Cancer ◽  
Metastatic Breast ◽  
Advanced Breast ◽  
Clinical Cancer Research ◽  
Cancer Project

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by Swiss Group for Clinical Cancer Research (SAKK) – Breast Cancer Project Group. Clinical trials include: Randomized phase III trial of Herceptin followed by chemotherapy plus Herceptin versus the combination of Herceptin and chemotherapy as palliative treatment in patients with HER2-overexpressing advanced/metastatic breast cancer. Protocol SAKK 22/99Trastuzumab monotherapy followed by the combination of trastuzumab and letrozole in post-menopausal women with ER-positive, HER-2 positive advanced breast cancer resistant to a nonsteroidal aromatase inhibitor. A multicenter two-step phase II trial Protocol SAKK 23/03Phase I–II trial of capecitabine and vinorelbine in elderly patients ( 65 years) with metastatic breast cancer with and without bone involvement. Protocol SAKK 25/99Phase I/II trial of capecitabine with weekly paclitaxel for advanced breast cancer. Protocol SAKK 26/00

Targeted tumor-derived cellular immunotherapy in advanced breast cancer patients induces initial immune responses and tumor regression.

2019 ◽  
Vol 37 (8_suppl) ◽  
pp. 6-6
Author(s):  
Vivekananda Sunkari ◽  
William Williams ◽  
George Peoples ◽  
Sanne Graeve ◽  
Charles Wiseman ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Metastatic Breast Cancer ◽  
Phase I ◽  
Advanced Breast Cancer ◽  
Tumor Regression ◽  
Metastatic Breast ◽  
Advanced Breast ◽  
Delayed Type Hypersensitivity ◽  
Sera Samples

6 Background: SV-BR-1-GM is a GM-CSF secreting breast cancer cell line which also expresses HLA class I & II antigens. In a previous clinical trial, a partial response of widely metastatic breast cancer was seen in a patient who allele-matched SV-BR-1-GM at HLA-DRB3. Here we report regression of metastatic breast cancer and efficacy analysis with immunologic correlates in subjects of a Phase I/IIa trial of SV-BR-1-GM in patients with advanced breast cancer. Methods: 24 patients with recurrent and/or metastatic breast cancer refractory to standard therapies have been dosed with SV-BR-1-GM in a Phase I/IIa trial. Patients who have undergone at least one cycle of SV-BR-1-GM therapy were analyzed. Patients first received low-dose cyclophosphamide, then intradermal injection of SV-BR-1-GM (20-40x106 cells/four sites) with interferon-α injected into inoculation sites (10,000 IU/site) ~2 & 4 days subsequently. Immunologic responses were measured by delayed type hypersensitivity (DTH) after inoculation and IgG titers of antibodies against SV-BR-1 were measured in sera samples collected prior to and after the first dose of SV-BR-1-GM by flow cytometry. Results: 24 patients have been inoculated with SV-BR-1-GM cells with no unexpected adverse events. None of the patients exhibited immediate hypersensitivity to SV-BR-1. DTH response was recorded in 18 subjects till date, of these, 61% exhibited DTH to cell inoculations. The patient with the most marked DTH response, 01-002, also had a clinical response with regression of multiple lung metastases. Two other patients had evidence of tumor regression (tumor regression is matched SV-BR-1-GM at least at one HLA allele). Sera samples from 6 patients were evaluated and found to contain anti-SV-BR-1 antibodies. Conclusions: SV-BR-1-GM in this regimen appears to be safe and well-tolerated. Initial analysis of SV-BR-1-GM showed significant DTH and antibody responses. HLA matching improves the response rate and is being evaluated as a predictor of response. Clinical trial information: NCT03066947.

Weekly Docetaxel in the Treatment of Elderly Patients With Advanced Breast Cancer: A Minnie Pearl Cancer Research Network Phase II Trial

2001 ◽  
Vol 19 (15) ◽  
pp. 3500-3505 ◽  
Author(s):  
John D. Hainsworth ◽  
Howard A. Burris ◽  
Denise A. Yardley ◽  
James E. Bradof ◽  
Manuel Grimaldi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Advanced Breast Cancer ◽  
Performance Status ◽  
Metastatic Breast ◽  
Poor Performance ◽  
Advanced Breast ◽  
Poor Performance Status ◽  
Line Treatment ◽  
Weekly Docetaxel

PURPOSE: To evaluate the efficacy and toxicity of docetaxel administered weekly to elderly or poor-performance status patients with advanced breast cancer. PATIENTS AND METHODS: Forty-one patients with advanced breast cancer who were either over the age of 65 or considered to be poor candidates for combination chemotherapy received docetaxel 36 mg/m2 weekly for 6 consecutive weeks, followed by 2 weeks without treatment. The median age of patients in this trial was 74 years, and 73% of patients had one or more visceral sites of metastases. Seventy-five percent of patients received weekly docetaxel as first-line treatment for metastatic breast cancer, and the other 25% received it as second-line treatment. Thirty-six patients were assessable for efficacy, and all patients were assessed for toxicity. RESULTS: A total of 448 doses of weekly docetaxel were administered to 41 patients. Thirteen patients (36%) had objective responses to treatment, and an additional 13 patients (36%) had stable disease or minor response. Median time to progression for responding and stable patients was 7 months (range, 3 to 27 months). Median survival for the entire group was 13 months, with 1- and 2-year actuarial survival rates of 61% and 29%, respectively. Severe neutropenia occurred in only 0.4% of courses, and no other hematologic toxicity was observed. Grade 3/4 fatigue was the most common toxicity, occurring in 20% of patients. CONCLUSION: Weekly docetaxel therapy is active and well tolerated by elderly and/or poor-performance status patients with advanced breast cancer. This treatment can be administered with minimal myelosuppression. Weekly docetaxel provides an additional option for treatment in this difficult subgroup of patients with metastatic breast cancer. Well-tolerated combination regimens containing weekly docetaxel merit evaluation for this patient population.

Abstract 5371: The Metastatic Breast Cancer Project: Partnering with patients to accelerate progress in cancer research

2018 ◽  
Author(s):  
Nikhil Wagle ◽  
Corrie Painter ◽  
Elana Anastasio ◽  
Michael Dunphy ◽  
Mary McGillicuddy ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Research ◽  
Metastatic Breast Cancer ◽  
Metastatic Breast ◽  
Cancer Project

scholarly journals Precision Medicine for Metastatic Breast Cancer

2015 ◽  
pp. e2-e7 ◽  
Author(s):  
Elise Deluche ◽  
Elisa Onesti ◽  
Fabrice Andre
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Dna Repair ◽  
Metastatic Breast Cancer ◽  
Phase I ◽  
Precision Medicine ◽  
Metastatic Breast ◽  
Nucleotide Polymorphisms ◽  
Genomic Alterations ◽  
Pik3ca Mutations

Genomic studies have shown that large numbers of candidate targets are observed in breast cancer. Nevertheless, only a few of them are validated as relevant targets in clinical studies. Estrogen receptor (ER) and HER2 expressions could be associated with a level I evidence. Beyond ER and HER2, BRCA and PIK3CA mutations (when targeted with alpha-specific PI3K inhibitors) could be considered as promising targets in breast cancer since they have been associated with objective responses in phase I/II trials. In addition to these four molecular alterations, several others have shown promising results in preclinical studies and are being investigated in clinical trials. These genomic alterations include AKT1, ERBB2, and ESR1 mutations. These considerations highlight the lack of evidence for using multiplex technologies to individualize therapy in metastatic breast cancer. Sequencing multiple genes to treat metastatic breast cancer is very promising but should be done in the context of clinical trials, either to enrich phase I/II trials in patients with genomic alterations or to show medical usefulness of new biotechnologies like next-generation sequencing (NGS). Although most current approaches of precision medicine are aiming at targeting drivers, additional applications could be developed in the future. This includes the identification of DNA repair deficiencies, mechanisms of immune suppression, and identification of minority lethal subclones. Finally, one of the very promising applications of genomics for metastatic breast cancer is the identification of pathway activation or defects at the individual level. For example, gene expression and single nucleotide polymorphisms (SNP) signatures are being developed to detect kinase (such as mammalian target of rapamycin [mTOR]/CDK4) activations or DNA repair deficiencies.

Fulvestrant ('Faslodex')--a new treatment option for patients progressing on prior endocrine therapy.

2002 ◽  
pp. 267-276 ◽  
Author(s):  
C Morris ◽  
A Wakeling
Keyword(s):  
Breast Cancer ◽  
Estrogen Receptor ◽  
Metastatic Breast Cancer ◽  
Advanced Breast Cancer ◽  
Postmenopausal Women ◽  
Endocrine Therapy ◽  
Metastatic Breast ◽  
Advanced Breast ◽  
Phase Iii ◽  
Hormone Receptor Positive

Since its introduction more than 30 years ago, tamoxifen has been the most widely used endocrine therapy for the treatment of women with advanced breast cancer. More recently, a number of alternative endocrine treatments have been developed, including several selective estrogen receptor modulators (SERMs), aromatase inhibitors (AIs) and, most recently, fulvestrant ('Faslodex'). Fulvestrant is an estrogen receptor (ER) antagonist, which, unlike the SERMs, has no known agonist (estrogenic) effect and downregulates the ER protein. Tamoxifen is effective and well tolerated, although the non-steroidal AIs, anastrozole and letrozole, are more effective treatments for advanced disease than tamoxifen. Fulvestrant has recently gained US Food and Drug Administration approval for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy. In two global phase III clinical trials fulvestrant was at least as effective and as equally well tolerated as anastrozole for the treatment of postmenopausal women with advanced and metastatic breast cancer. In a retrospective analysis of the combined data from these trials, mean duration of response was significantly greater for fulvestrant compared with anastrozole. These new hormonal treatments expand the choice of endocrine therapy for women with advanced breast cancer and offer new options for sequencing and combining treatments.

Maximizing metastatic breast cancer therapy selection: Physician practice patterns and competence assessment.

2012 ◽  
Vol 30 (27_suppl) ◽  
pp. 127-127
Author(s):  
Tina Boyd Stacy ◽  
Maureen E. Haas ◽  
Alison A. Heintz
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Advanced Breast Cancer ◽  
Patient Care ◽  
Practice Patterns ◽  
Scientific Information ◽  
Single Agent ◽  
Metastatic Breast ◽  
Advanced Breast ◽  
Peer Discussion

127 Background: Due to the volume and pace of scientific advances within oncology, peer discussion and professional reflection regarding appropriate therapeutic decision making is necessary to provide the highest quality patient care. Increasing awareness in the breast cancer community of similarities and differences amongst practice management strategies helps to identify and benchmark individual practice patterns against one’s professional peers, ultimately leading to increased competence in therapy selection. Methods: During 2011 and 2012, educational outcomes assessments were gathered during 85 independent continuing medical education (CME) activities held within community practices and institutions across the USA. Participants were asked a series of case-based questions via an audience response system to assess baseline knowledge, competence, and identify practice patterns. Assessments were repeated post a 1-hour CME certified activity, with an additional 6-week electronic follow-up. Results: To date, over 330 physicians have participated in the program. Number of years in practice ranged from < 10 to > 30. The number of breast cancer patients seen per month ranged from ≤ 10 to > 40. Provider competency and preferences in applying guideline based therapy was assessed. Results of participant preferences including single-agent, combination, first-line, and second-line therapy preferences as well as toxicity management for select patient case scenarios in advanced breast cancer will be presented. Self-rated competence for the physician audience improved by approximately 50% as a result of participation. Conclusions: The results highlight the diversity of clinical opinion in selecting therapy for advanced breast cancer and need for continued dialogue and scientific advancement. Education and peer discussion of how to optimize translation of new scientific information into patient care contributes to maximizing physician competence in therapy selection for metastatic breast cancer.

Tracking evolution of aromatase inhibitor resistance with circulating tumour DNA (ctDNA) in metastatic breast cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 1015-1015
Author(s):  
Charlotte Victoria Fribbens ◽  
Isaac Garcia-Murillas ◽  
Matthew Beaney ◽  
Sarah Hrebien ◽  
Karen Howarth ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Advanced Breast Cancer ◽  
Disease Progression ◽  
Metastatic Breast ◽  
Advanced Breast ◽  
Plasma Samples ◽  
First Line ◽  
Ras Mutations ◽  
Esr1 Mutations

1015 Background: Selection of resistance mutations may play a major role in the development of endocrine resistance. ESR1 mutations are rare in primary breast cancer but have a high prevalence in patients treated with aromatase inhibitors (AI) for advanced breast cancer. We investigated the evolution of genetic resistance to first line AI therapy using sequential ctDNA sampling in patients with advanced breast cancer. Methods: Seventy-one patients on first line AI therapy for metastatic breast cancer were enrolled in a prospective study to collect plasma samples for ctDNA analysis every three months on therapy, and at disease progression. All plasma samples were analysed with ESR1 multiplex digital PCR assays, and samples at disease progression were analysed by InVision (enhanced tagged-amplicon sequencing). Mutations were tracked back through samples prior to disease progression to study the evolution of mutations on therapy. Results: Of the 34 patients who progressed on first line AI, 53% (18/34) had ESR1 mutations detectable at progression. Sequencing of progression plasma ctDNA identified polyclonal RAS mutations in 10.7% (3/28) progressing patients (2 polyclonal KRAS, 1 monoclonal HRAS), all of whom also had ESR1 mutations, and a patient with an activating p.R248C FGFR3 mutation. ESR1 mutations were subclonal in 78.6% (11/14) patients, with all RAS mutations being rare subclones. In serial tracking prior to progression, ESR1 mutations were detectable in plasma with a median of 5.3 months (95% CI 2.9-NA) prior to clinical progression. Conclusions: ESR1 mutations are found at high frequency in patients progressing on AI, but are frequently sub-clonal and may not be the sole driver of AI resistance in these patients. Poly-clonal KRAS mutations are identified as a novel mechanism of resistance to AI, associated with detection of ESR1 mutations.

Fulvestrant in advanced breast cancer following following failure of tamoxifen and a third generation aromatase inhibitor

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 1073-1073
Author(s):  
J. Wang ◽  
S. Jain ◽  
W. Heller ◽  
D. Mackie ◽  
V. Watson ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Estrogen Receptor ◽  
Metastatic Breast Cancer ◽  
Advanced Breast Cancer ◽  
Aromatase Inhibitor ◽  
Endocrine Therapy ◽  
Locally Advanced ◽  
Metastatic Breast ◽  
Advanced Breast ◽  
Third Generation

1073 Background: Endocrine therapy is a key modality in the management of estrogen receptor positive metastatic breast cancer. Fulvestrant (ICI 182,780) is an estrogen receptor downregulator. It has previously been shown to be as effective as anastrozole in patients who had previously progressed on tamoxifen. Methods: A retrospective study was carried out of metastatic breast cancer patients treated at Charing Cross Hospital between 2002–2005 who had received fulvestrant following treatment failure with tamoxifen and a third generation aromatase inhibitor. All patients were postmenopausal and received fulvestrant 250mg IM every 28 days. Measurable disease was assessed by response evaluation criteria in solid tumors (RECIST). Results: A total of 45 patients were identified with a median age of 60 (range 36 to 90). The ER status was known in 95% (n=43) of patients and was positive in all cases, it was unknown in 2% (n=2). At the time of commencing fulvestrant, 96% (n=43) had metastatic disease and 4% (n=2) locally advanced disease. All patients had received at least 2 lines of prior endocrine therapy (including adjuvant therapy), at time of starting fulvestrant the median number of prior regimens was 3 (range 3–5). Fulvestrant was administered for a median of 4 months (range 1 to 20 months), with 4 patients currently still receiving therapy as of 1 November 2006. Of the 45 patients, 2.2% (n=1) achieved a partial response, while 31% (n=14) achieved stable disease for at least 6 months. Thus, 33.3% (n=15) obtained clinical benefit (defined as PR or SD for at least 6 months). The response rates based on line of therapy will be presented. Of the 45 patients, 41 were evaluable for survival data. The median survival of the remaining patients from the start of fulvestrant therapy was 9 months (range 1 to 48 months). Of the 44 patients, 14% (n=6) remain alive. The treatment was well tolerated and toxicity data will be presented. Conclusions: Fulvestrant is well tolerated and is efficacious as treatment for advanced breast cancer that has failed tamoxifen and a third generation aromatase inhibitors. No significant financial relationships to disclose.

A 5-year review of an educational program focused on meeting the needs of patients with advanced breast cancer.

2012 ◽  
Vol 30 (27_suppl) ◽  
pp. 87-87
Author(s):  
Ivy A. Ahmed ◽  
Allison Harvey ◽  
Marni Amsellem
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Advanced Breast Cancer ◽  
Metastatic Breast ◽  
Breast Cancer Diagnosis ◽  
Health Care Team ◽  
Advanced Breast ◽  
Healthcare Team ◽  
Cancer Support ◽  
High Level

87 Background: Women living with advanced breast cancer have distinct often unmet needs, even compared to other women with breast cancer. For the past five years, the Cancer Support Community has been committed to delivering Frankly Speaking About Cancer: Advanced Breast Cancer, a comprehensive psychosocial education program created for women with metastatic breast cancer and their families. The program’s clinically facilitated evidence-based education workshops have reached 2,690 attendees since its inception in 2006. The workshop provides valuable information about current treatments, clinical trials, side-effect management, and social and emotional challenges of an advanced breast cancer diagnosis. Workshop outcomes are analyzed annually, informing program content and ensuring the program is meeting the needs of those served. As the program enters its sixth year, data were consolidated across years to investigate how the program has been meeting the needs of these women and their loved ones. Methods: 1,827 workshop attendees since the program’s beginning have completed evaluations (68% response rate) which included assessing levels of pre- and post-workshop knowledge about advanced breast cancer, patient-provider communication, and general workshop feedback. Results: 64.9% of respondents were survivors, 78.5% were Caucasian, and the average age was 56. Most workshop respondents (89.6%) reported gaining a high or very high level of knowledge about advanced breast cancer, with significant increases compared with pre-workshop levels (p <.01). Most reported intent to increase communication with their clinical team following the workshop. A majority reported feeling better equipped to ask questions to their health care team (92.1%), and discuss the possibility of clinical trials with their healthcare team (77.7%). Furthermore, 90% of attendees felt confident that after the workshop they could speak knowledgably about side effects of cancer treatment with their doctor, a key issue in regards to quality of life. Conclusions: Taken together, the data indicate the continued relevance of this program for those affected by advanced breast cancer.

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