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Phase 2 Neoadjuvant Doxorubicin and Cyclophosphamide -> Docetaxel With Lapatinib in Stage II/III Her2Neu+ Breast Cancer
Not Recruiting
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This trial combines dose dense chemotherapy with doxorubicin and cyclophosphamide (AC)
followed by standard, every 3 week docetaxel and GW572016 (lapatinib) for neoadjuvant
treatment of Her2neu positive stage II/III breast cancer. The purpose of the study was to
determine whether lapatinib combined with chemotherapy was safe and resulted in an increase
in pathologic complete response rates.
Stanford is currently not accepting patients for this trial.
For more information, please contact Mary Chen, 6507238686.
Stanford Investigators
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A Study of AC Followed by a Combination of Paclitaxel Plus Trastuzumab or Lapatinib or Both Given Before Surgery to Patients With Operable HER2 Positive Invasive Breast Cancer
Not Recruiting
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The primary purpose of this study is to determine whether breast cancer tumors respond (as
measured by pathologic complete response: the absence of microscopic evidence of invasive
tumor cells in the breast) to combined chemotherapy of AC(doxorubicin and cyclophosphamide)
followed by paclitaxel plus trastuzumab or lapatinib or both given before surgery to patients
with HER2-positive breast cancer. Trastuzumab will also be given to all patients after
surgery. The study will also evaluate the toxic effects of the chemotherapy combination,
including effects on the heart, and will determine survival and progression-free survival 5
years after treatment. Also, the study will look at whether there are gene expression
profiles in the tumor tissue that can predict pathologic complete response.
Stanford is currently not accepting patients for this trial.
For more information, please contact Marilyn Florero, 6507241953.
Stanford Investigators
View full details
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Phase 2 Study of Gemzar, Taxol & Avastin Combination as 1st Line Treatment for Metastatic Breast Cancer
Not Recruiting
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Single-institution phase 2 trial investigating the efficacy of capecitabine, oxaliplatin and
bevacizumab for patients with metastatic neuroendocrine tumors.
Stanford is currently not accepting patients for this trial.
For more information, please contact Mary Chen, 6507238686.
Stanford Investigators
View full details
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S0307 Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer.
Not Recruiting
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RATIONALE: Zoledronate, clodronate, or ibandronate may delay or prevent bone metastases in
patients with nonmetastatic breast cancer. It is not yet known whether zoledronate is more
effective than clodronate or ibandronate in treating breast cancer.
PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works
compared to clodronate or ibandronate in treating women who have undergone surgery for stage
I, stage II, or stage III breast cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Mary Chen, 6507238686.
Stanford Investigators
View full details
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Sleep, Circadian Hormonal Dysregulation, and Breast Cancer Survival
Not Recruiting
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Recent research provides evidence that disrupted circadian rhythms, including hormonal
patterns and sleep, are associated with increased risk of breast cancer incidence and faster
progression to mortality. We have observed that a loss of normal diurnal cortisol rhythm
associated with more awakenings during the night predicts early mortality with metastatic
breast cancer. Other recent studies have shown that nighttime shift work is associated with
higher breast cancer incidence, and in a murine model disrupting circadian cortisol cycles
produced a doubling of implanted tumor growth. There is also recent evidence that abnormal
clock genes are associated with cancer. However, it is not clear whether sleep disruption per
se affects breast cancer progression, or whether such an effect is mediated by hormonal and
immune dysregulation of this prevalent and hormone-mediated cancer. We propose to study sleep
disruption as a prognostic factor in the progression of metastatic breast cancer. We will
also examine sleep patterns in association with disrupted circadian rhythms of cortisol,
ACTH, and melatonin as well as measures of immune function known to be salient to breast
cancer progression. These are natural killer cell cytoxicity and specific cytokine, IL-6. We
plan to recruit 105 women 45 years through 75 years with metastatic or recurrent breast
cancer and 20 age and SES-matched controls for a two-week at home sleep study with Actiwatch
and two nights of in-home EEG monitoring, followed by 28 hours of continuous blood sampling
and one night of EEG sleep monitoring in our lab at Stanford. This will provide a full
examination of circadian hormones associated with sleep patterns. We will relate these
assessments to the subsequent course of breast cancer progression. Results of this study will
provide specific evidence regarding how improved sleep management may affect the course of
breast cancer. Aim 1: To study 24-hr diurnal rhythms of HPA axis hormones and melatonin in
women with metastatic or recurrent breast cancer. Hypothesis 1: Women with metastatic or
recurrent breast cancer will have reduced amplitude and disrupted phase of 24-hr diurnal
rhythms of cortisol, ACTH, and melatonin. Aim 2: To describe sleep disruption in women with
metastatic breast cancer and examine psychosocial, endocrine, and immune factors that may be
associated with sleep disruption. Hypothesis 2: Women with metastatic or recurrent breast
cancer will have a higher incidence of both at home and laboratory-examined sleep disruption
than control women without breast cancer. Hypothesis 3: Poorer sleep quality will be
associated with more pain, more emotional suppression in response to stressors, less
emotional support, greater depression and anxiety, and greater perceived and traumatic
stress. Hypothesis 4: Poorer sleep quality and quantity of sleep and daytime sleepiness and
fatigue will be associated with abnormal circadian neuroendocrine (i.e., cortisol, ACTH, and
melatonin) and immune patterns (i.e., suppressed day and night time NK activity and loss of
NK rhythms; increased day time IL-6 levels and /or loss of IL-6 rhythm). Aim 3: To study the
relationship between sleep disruption and survival time among metastatic and recurrent breast
cancer patients. Hypothesis 5: Poorer sleep quality and quantity of sleep will predict
shorter survival. Hypothesis 6: Reduced diurnal amplitude and an abnormal phase of cortisol
will predict shorter survival. Explanatory Aim 4: To investigate whether sleep disruption
mediates the relation of psychosocial factors to health outcomes.
Stanford is currently not accepting patients for this trial.
For more information, please contact Bita Nouriani, 6507238479.
Lead Sponsor
Stanford Investigators
View full details
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Pilot Study to Determine Radioiodide Accumulation and Dosimetry in Breast Cancers Using 124I PET/CT
Not Recruiting
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This is a pilot imaging study for women whose tumors express NIS [Na+I- symporter, sodium
iodide symporter]. Eligibility is limited to the presence of strong (3+) and/or plasma
membrane staining in > 20% of cells as determined by immunohistochemical methods. A total of
10 patients will be imaged with 124I PET/CT (serial scans over 24 hour period) to determine
radioiodide uptake and distribution in tumor tissue. Thyroid iodide uptake and retention will
be blocked beginning one week prior to 124I PET/CT scan with thyroid hormone (T3) and
methimazole (impedes organification). Tumor, organ and whole body dosimetry will be
calculated in each patient.
Stanford is currently not accepting patients for this trial.
For more information, please contact Marilyn Florero, 6507241953.
Lead Sponsor
Stanford Investigators
View full details
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A Phase 3, Multi-Center Study of Gemcitabine/Carboplatin, With or Without BSI-201, in Patients With ER-, PR-, and Her2-Negative Metastatic Breast Cancer
Not Recruiting
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The goal of this study was to determine the effect on overall survival and progression free
survival by adding iniparib (BSI-201/SAR240550) to the combination of gemcitabine/carboplatin
in adult patients with triple negative breast cancer (estrogen receptor (ER)-negative,
progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2
(HER2)-negative).
Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess
characteristics typical of the poly (ADP-ribose) polymerase (PARP) inhibitor class. The exact
mechanism has not yet been fully elucidated, however based on experiments on tumor cells
performed in the laboratory, iniparib is a novel investigational anti-cancer agent that
induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in
the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging
modalities in tumor cell lines. Investigations into potential targets of iniparib and its
metabolites are ongoing.
Stanford is currently not accepting patients for this trial.
For more information, please contact Charlene Kranz, 6504987977.
Stanford Investigators
View full details
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Intellectual Impairment in Women With Breast Cancer
Not Recruiting
More
RATIONALE: Breast cancer and its treatment may cause changes in a patient's ability to think,
learn, and remember. Gathering information about a woman's genes, brain function, and
personal history may help doctors learn more about the disease and plan the best treatment.
PURPOSE:
1. To determine changes in brain function that occur following breast cancer chemotherapy.
2. To gain further understanding of the individual differences in brain function changes
and recovery based on demographic, medical and treatment variables.
Stanford is currently not accepting patients for this trial.
For more information, please contact Shelli Kesler, PhD, 650-723-0058.
Lead Sponsor
Stanford Investigators
View full details
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Phase 2 Anastrozole and Vandetanib (ZD6474) in Neoadjuvant Treatment of Postmenopausal Hormone Receptor-Positive Breast Cancer
Not Recruiting
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In this study we plan to study the combination of ZD6474, a dual inhibitor of EGFR and
VEGFR-2 with anastrozole in the neoadjuvant setting for patients with Stage I-III breast
cancer. The aim is to overcome mechanisms of resistance and simultaneously block multiple
critical signaling pathways known to stimulate breast cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Marcy Chen, 6507238686.
Lead Sponsor
Stanford Investigators
View full details
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A Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer
Not Recruiting
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The main purpose of this study is to learn if adding bevacizumab to standard treatment with
chemotherapy (docetaxel, doxorubicin, and cyclophosphamide) for early stage HER2-negative
breast cancer will prevent breast cancer from returning. A second purpose of this study is to
learn if adding bevacizumab to treatment with chemotherapy will help women with HER2-negative
breast cancer live longer. The researchers also want to learn about the side effects of the
combination of drugs used in this study.
Stanford is currently not accepting patients for this trial.
For more information, please contact Marilyn Florero, 6507241953.
Stanford Investigators
View full details
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Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
Not Recruiting
More
RATIONALE: Estrogen can stimulate the growth of breast tumor cells. Ovarian function
suppression combined with hormone therapy using tamoxifen or exemestane may fight breast
cancer by reducing the production of estrogen. It is not yet known whether suppression of
ovarian function plus either tamoxifen or exemestane is more effective than tamoxifen alone
in preventing the recurrence of hormone-responsive breast cancer.
PURPOSE: This randomized phase III trial studies ovarian suppression with either tamoxifen or
exemestane to see how well they work compared to tamoxifen alone in treating premenopausal
women who have undergone surgery for hormone-responsive breast cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Marilyn Florero, 6507241953.
Stanford Investigators
View full details
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A Safety and Immunology Study of a Modified Vaccinia Vaccine for HER-2(+) Breast Cancer After Adjuvant Therapy
Not Recruiting
More
The current trial, BNIT-BR-003, will evaluate the safety and biological activity of a fixed
dose of MVA-BN®-HER2 following adjuvant chemotherapy in patients with HER-2-positive breast
cancer.
The intent of vaccination is to induce a combined antibody and T-cell anti-HER-2 immune
response, which is intended to target HER-2-expressing tumor cells, and may induce tumor
regression or slow progression of disease.
Stanford is currently not accepting patients for this trial.
For more information, please contact Mary Chen, 6507238686.
Stanford Investigators
View full details
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Anastrozole and ZD1839 Compared With Fulvestrant and ZD1839 in Postmenopausal Women w/ Metastatic Breast Cancer
Not Recruiting
More
This randomized phase II trial is studying how well giving gefitinib together with
anastrozole works compared to giving gefitinib together with fulvestrant in treating
postmenopausal women with recurrent or metastatic breast cancer. Estrogen can stimulate the
growth of breast cancer cells. Hormone therapy using anastrozole and fulvestrant may fight
breast cancer by blocking the use of estrogen. Gefitinib (ZD1839) may stop the growth of
cancer cells by blocking the enzymes necessary for their growth. It is not yet known whether
gefitinib is more effective when combined with anastrozole or fulvestrant in treating breast
cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Nancy Mori, 6507240201.
Stanford Investigators
View full details
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Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer; Chemotherapy as Adjuvant for LOcally Recurrent Breast Cancer
Not Recruiting
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. It is not yet known whether chemotherapy is effective in treating
women who have undergone surgery and radiation therapy for relapsed breast cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of adjuvant chemotherapy
in treating women who have undergone resection for local and/or regional relapsed breast
cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Marilyn Florero, 6507241953.
Stanford Investigators
View full details
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Comparison of Two Combination Chemotherapy Regimens in Treating Women With Breast Cancer
Not Recruiting
More
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, epirubicin, cyclophosphamide,
and doxorubicin, work in different ways to stop tumor cells from dividing so they stop
growing or die. It is not yet known which combination chemotherapy regimen is more effective
in treating breast cancer.
PURPOSE: This randomized phase III trial is studying two combination chemotherapy regimens to
compare how well they work in treating women who have undergone surgery for breast cancer
that has not spread to the lymph nodes.
Stanford is currently not accepting patients for this trial.
For more information, please contact Marilyn Florero, 6507241953.
Stanford Investigators
View full details
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S0500 Treatment Decision Making Based on Blood Levels of Tumor Cells for Metastatic Breast Cancer Treated With Chemo
Not Recruiting
More
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor
cells, either by killing the cells or by stopping them from dividing. Measuring blood levels
of tumor cells may help in learning how well chemotherapy works to kill metastatic breast
cancer cells and allow doctors to plan better treatment. When blood levels of tumor cells are
high while receiving chemotherapy, it is not yet known whether it is more effective to change
chemotherapy regimens at that time or wait until disease progression.
PURPOSE: This randomized phase III trial is studying treatment decision making based on blood
levels of tumor cells in women with metastatic breast cancer receiving chemotherapy.
Stanford is currently not accepting patients for this trial.
For more information, please contact Pei-Jen Chang, 6507250866.
Stanford Investigators
View full details
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Vitamin D and Breast Cancer: Does Weight Make a Difference?
Not Recruiting
More
This is a research study of the effect of Vitamin D on breast cancer. We hope to learn
whether Vitamin D can change characteristics of certain genes in a breast cancer tumor that
affect its growth. We believe some of these characteristics may be influenced by body weight.
Stanford is currently not accepting patients for this trial.
For more information, please contact Sumita Sood, 650-723-0186.
Stanford Investigators
View full details
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Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer
Not Recruiting
More
This randomized phase III clinical trial studies chemotherapy with or without trastuzumab
after surgery to see how well they work in treating women with invasive breast cancer. Drugs
used in chemotherapy work in different ways to stop the growth of tumor cells, either by
killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving
more than one drug (combination chemotherapy) and giving chemotherapy after surgery may kill
more tumor cells. Monoclonal antibodies, such as trastuzumab, can block cancer growth in
different ways. Some block the ability of tumor cells to grow and spread. Others find tumor
cells and help kill them or carry tumor-killing substances to them. It is not yet known
whether combination chemotherapy is more effective with trastuzumab in treating breast
cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Amy Isaacson, 650-723-0501.
Stanford Investigators
View full details
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A Pharmacokinetic and Randomized Trial of Neoadjuvant Treatment With Anastrozole Plus AZD0530 in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer
Not Recruiting
More
The investigators propose to conduct a Phase I/randomized Phase II study design in order to
test the tolerability and efficacy of AZD0530 (also called saracatinib) when used together
with anastrozole in therapy for ER+ and/or PR+, postmenopausal breast cancer. The Phase I
pharmacokinetic (PK) cohort of the study (cohort A) in postmenopausal women with metastatic
breast cancer 2008-2009 showed initial safety,tolerability and good bioavailability of both
drugs and determined the doses for use in the ongoing Phase II trial. In the randomized Phase
II cohort of the study (cohort B), postmenopausal women with newly diagnosed, previously
untreated ER+, HER2 negative breast cancer that is at least 2 cm or more in diameter by
clinical exam or radiology will be randomized to either neoadjuvant treatment with
anastrozole plus placebo, or anastrozole in combination with AZD0530 (saracatinib). The Phase
II cohort will permit extended assays of tolerability, initial estimates of efficacy, and the
investigation of molecular predictors of drug efficacy.
Stanford is currently not accepting patients for this trial.
For more information, please contact Annabel Castaneda, 650-498-7977.
Stanford Investigators
View full details
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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
Not Recruiting
More
There are no treatments specifically approved after recurrence or progression on a non
steroidal aromatase inhibitors (NSAI). In light of the need for new treatment options for
postmenopausal women after failure of prior NSAI therapy, the purpose of this Phase III study
is to compare efficacy and safety of a treatment with exemestane + everolimus to exemestane +
placebo in postmenopausal women with estrogen receptor positive locally advanced or
metastatic breast cancer refractory to NSAI.
Stanford is currently not accepting patients for this trial.
For more information, please contact Mary Chen, 6507238686.
Stanford Investigators
View full details
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A Safety and Immunology Study of a Modified Vaccinia Vaccine for HER-2(+) Metastatic Breast Cancer
Not Recruiting
More
The current trial, BNIT-BR-002, will evaluate the safety and biological activity of a fixed
dose of MVA-BN®-HER2, with and without Herceptin, following 1st- or 2nd-line chemotherapy in
patients with Her-2-positive metastatic breast cancer.
The intent of vaccination is to induce anti-Her-2 immune responses, both antibody and T cell,
that will then attack the Her-2 expressing tumors, and may induce tumor regression or slow
progression of disease.
Stanford is currently not accepting patients for this trial.
For more information, please contact Mary Chen, 6507238686.
Stanford Investigators
View full details
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A Phase 2 Study of Standard Chemotherapy Plus BSI-201 (a PARP Inhibitor) in the Neoadjuvant Treatment of Triple Negative Breast Cancer
Not Recruiting
More
This study will investigate whether the neoadjuvant combination of gemcitabine, carboplatin,
and BSI-201 will cause a high percentage of triple negative breast cancer patients to achieve
a pathologic complete response prior to surgery.
Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess
characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been
fully elucidated, however based on experiments on tumor cells performed in the laboratory,
iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of
DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell
lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines.
Investigations into potential targets of iniparib and its metabolites are ongoing.
Stanford is currently not accepting patients for this trial.
For more information, please contact Pei-Jen Chang, 6507250866.
Stanford Investigators
View full details
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Ph I/II of Vitamin D on Bone Mineral Density & Markers of Bone Resorption
Not Recruiting
More
Aromatase inhibitors are potent suppressors of breast cancer growth, but side effects include
bone loss, fractures, arthralgias and myalgias. We hypothesize vitamin D administration might
be beneficial in treating these symptoms and to protect bone.
Stanford is currently not accepting patients for this trial.
For more information, please contact Charlene Kranz, 6504987977.
Stanford Investigators
View full details
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Radiation Therapy (WBI Versus PBI) in Treating Women Who Have Undergone Surgery For Ductal Carcinoma In Situ or Stage I or Stage II Breast Cancer
Not Recruiting
More
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation
therapy in different ways may kill any tumor cells that remain after surgery. It is not yet
known whether whole breast radiation therapy is more effective than partial breast radiation
therapy in treating breast cancer.
PURPOSE: This randomized phase III trial is studying whole breast radiation therapy to see
how well it works compared to partial breast radiation therapy in treating women who have
undergone surgery for ductal carcinoma in situ or stage I or stage II breast cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Marilyn Florero, 6507241953.
Stanford Investigators
View full details
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A Safety and Immunology Study of a Modified Vaccinia Vaccine for HER-2(+) Breast Cancer After Adjuvant Therapy
Not Recruiting
More
The current trial, BNIT-BR-003, will evaluate the safety and biological activity of a fixed
dose of MVA-BN®-HER2 following adjuvant chemotherapy in patients with HER-2-positive breast
cancer.
The intent of vaccination is to induce a combined antibody and T-cell anti-HER-2 immune
response, which is intended to target HER-2-expressing tumor cells, and may induce tumor
regression or slow progression of disease.
Stanford is currently not accepting patients for this trial.
For more information, please contact Mary Chen, 6507238686.
Stanford Investigators
View full details
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Docetaxel and Cyclophosphamide Compared to Anthracycline-Based Chemotherapy in Treating Women With HER2-Negative Breast Cancer
Not Recruiting
More
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of breast
cancer cells, either by killing the cells or by stopping them from dividing. Giving the drugs
in different combinations may kill more breast cancer cells. Giving combination chemotherapy
after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This randomized phase III trial is studying different combination chemotherapy
regimens and their side effects and comparing how well they work in treating women with
non-metastatic breast cancer.
Stanford is currently not accepting patients for this trial.
For more information, please contact Donna Adelman, 650-724-1953.
Stanford Investigators
View full details
