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Home:
Educational
Supplement: Section 12
— Clinical
Trials
ACOSOG
Z0010: A PROGNOSTIC STUDY OF SENTINEL NODE AND BONE MARROW
MICROMETASTASES IN WOMEN WITH CLINICAL T1 OR T2 N0 M0 BREAST
CANCER
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This
study, sponsored by the American College of Surgeons, is enrolling
women with clinical T1 or T2 N0 M0 breast cancer who will
be undergoing breast-conserving therapy (BCT), bilateral iliac
bone marrow aspirations and sentinel lymph node dissection
(SLND).
THE
OBJECTIVES ARE:
- To estimate the prevalence and to evaluate the prognostic
significance of sentinel node micrometastases detected by
immunohistochemistry (IHC).
- To estimate the prevalence and to evaluate the prognostic
significance of bone marrow micrometastases detected by
immunocytochemistry (ICC).
- To evaluate the hazard rate for regional recurrence in
women whose sentinel nodes are negative by hematoxylin and
eosin (H&E) staining.
- To provide a mechanism for identifying women whose sentinel
nodes contain metastases detected by H&E, so that these
women can be considered as candidates for Study Z0011 (see
below).
The purpose
of this study is to evaluate the accuracy and long-term outcome
of sentinel node biopsy in a large group of women across the
United States. The sentinel lymph node(s) and bone marrow
aspirate will be sent to an independent laboratory for immunohistochemistry
studies. The results of these studies will not be released
to physicians or patients since the importance of these results
is uncertain. All participants will be monitored for cancer
recurrence.
For
further information please contact Simbi Acharya at 312.926.9930
or s-acharya@northwestern.edu
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ACOSOG
Z0011: A RANDOMIZED TRIAL OF AXILLARY NODE DISSECTION IN WOMEN
WITH CLINICAL T1-2 N0 M0 BREAST CANCER WHO HAVE A POSITIVE
SENTINEL NODE
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Women
with clinical stage T1 or T2 N0 M0 breast cancer will undergo
sentinel lymph node dissection with breast-conserving therapy.
Women who are found to have a sentinel node containing metastatic
breast cancer, as documented on frozen section, touch prep
or permanent section evaluation by hematoxylin and eosin (H&E)
staining, will be randomized to one of two arms:
- Arm 1: Completion axillary lymph node dissection (ALND).
- Arm 2: No immediate additional axillary surgery or
axillary-specific radiation.
Women
in both arms will have whole-breast radiation and systemic
adjuvant therapy. Women who participate in this study may
also be registered to study Z0010, but this is not required
for participation in Z0011.
THE
PRIMARY OBJECTIVES ARE:
Long-term:
To assess whether overall survival for patients randomized
to Arm 2 (no ALND) is essentially equivalent to (or better
than) that for patients assigned to Arm 1 (completion ALND).
Short-term: To quantify and compare the surgical morbidities
associated with SLND plus ALND versus SLND alone.
This
study is trying to determine if axillary node removal contributes
to the cure of breast cancer. Participants will be followed
to determine the long-term effects of sentinel lymph node
dissection alone, on patients with positive sentinel nodes,
and whether patient outcomes differ with standard axillary
dissection.
For
further information please contact Simbi Acharya at 312.926.9930
or s-acharya@northwestern.edu
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NCI
00B1: A PROSPECTIVE STUDY OF BREAST DENSITY AND SALIVARY HORMONE
LEVELS IN PREMENOPAUSAL WOMEN
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Funded
by Avon, this one-year study uses the recently FDA-approved
digital mammography to determine whether breast density changes
with the menstual cycle.
PRIMARY
OBJECTIVES:
- To determine if breast density, as measured by digital
mammography, fluctuates significantly during the menstrual
cycle.
- To determine if breast density, as determined by a
trained mammographer, fluctuates significantly during the
menstrual cycle.
SECONDARY
OBJECTIVE:
- To determine if fluctuations in breast density vary
with patient characteristics such as body mass index or
level of breast cancer risk.
THE
BASIC ELIGIBILITY CRITERIA ARE:
- Women must be between ages 30-50 and be premenopausal
- Women must be undergoing annual mammography
- Women must have a clinical breast exam that is not suspicious
for malignancy
- Women must not have been diagnosed with breast cancer
- Women cannot be taking hormones such as oral contraceptives
and hormone replacement therapy or tamoxifen
- Women cannot be pregnant nor planning pregnancy during
the study
This study
will provide important information on the relationship of
breast density to the menstrual cycle, which has clinical
implications for the scheduling of mammography in the population
of premenopausal women undergoing diagnostic or screening
breast imaging.
For
further information please contact Simbi Acharya at 312.926.9930
or s-acharya@northwestern.edu
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NCI
00B2: A PROSPECTIVE STUDY OF THE EFFECT OF TAMOXIFEN ON BREAST
DENSITY IN PREMENOPAUSAL WOMEN
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This
five-year study funded by Avon is evaluating the effects of
tamoxifen on breast density using the recently FDA-approved
digital mammography technique. Effects of tamoxifen will be
closely monitored to see if they are related to hormone fluctuations.
PRIMARY
OBJECTIVES:
- To determine if breast density, as measured by digital
mammography, decreases in premenopausal women taking tamoxifen
for breast cancer treatment or risk reduction.
- To determine if breast density, as determined by a trained
mammographer, decreases in premenopausal women taking tamoxifen
for breast cancer treatment or risk reduction.
- To determine if tamoxifen-induced symptoms in estrogen
target tissues correlate with change in salivary hormones.
SECONDARY
OBJECTIVES:
- To determine the effect of tamoxifen on salivary steroids
in regularly cycling and amenorrheic women on tamoxifen.
- To determine the relationship between changes in breast
density and tamoxifen-induced alterations in sex steroid
levels as measured in the saliva.
THE
BASIC ELIGIBILITY CRITERIA ARE:
- Women must be between ages 20-45 and premenopausal
- Women must be initiating tamoxifen as the sole systemic
treatment for carcinoma or breast cancer risk reduction
- Women cannot have bilateral breast cancer
- Women must be undergoing annual mammography
- Women cannot have taken tamoxifen in the past for more
than one month
- Women cannot be pregnant or planning pregnancy during
the study
This study
will provide important information about the effect of tamoxifen
therapy on breast density in premenopausal women and correlate
changes in breast density with changes in sex steroid levels
in the saliva.
For
further information please contact Simbi Acharya at 312.926.9930
or s-acharya@northwestern.edu
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NU
01B1: THE UTILITY OF DUCTAL LAVAGE IN THE DIAGNOSIS OF EARLY
DUCTAL LESIONS: A PILOT STUDY
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Partially
funded by ProDuct Health, Inc., the purpose of this study
is to evaluate whether findings from ductal lavage are accurate
compared to biopsy and to establish the best way to combine
ductal lavage and biopsy techniques. Ductal lavage is a new
technique to collect breast ductal cells. Prior to undergoing
a recommended breast biopsy for microcalcifications, the participant
will undergo ductal lavage and ductography.
THE
BASIC ELIGIBILITY CRITERIA ARE:
- Women must be over the age of 18 years
- Recommendation to have a breast biopsy to evaluate mammographically
detected microcalcifications
ADDITIONAL
CRITERIA INCLUDE:
- Not currently pregnant or within the past 12 months
- Has not lactated within the prior 12 months
- No chemotherapy within the past six months
- Never taken tamoxifen or raloxifene
- No active infection in the breast to be studied
- No known allergy to lidocaine, prilocaine, bupivacaine
or iodine
For
further information please contact Carol Baird at 312.926.0890
or cbaird@nmff.org
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NU
00B2: A CONTINUOUS-RISK DECISION AID FOR DUCTAL CARCINOMA
IN SITU
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The
increased use of screening mammography has resulted in a dramatic
increase in the detection rate of ductal carcinoma in situ
(DCIS). Unlike the more common invasive carcinoma, which has
the ability to spread to other parts of the body, DCIS is
a problem that is localized to the breast and has a very small
risk of cancer death. Little is known about the natural history
of DCIS because it has traditionally been treated with mastectomy,
but it is believed that if left untreated it will progress
to invasive carcinoma. However, the time to progression may
be extremely prolonged. This has led to a bewildering variety
of treatments for DCIS including mastectomy, lumpectomy and
radiation, or lumpectomy alone. Tamoxifen may be added to
any of these treatments.
Since
the survival differences among treatments are very small,
other factors such as the importance to a woman of retaining
her breast, her attitude toward further surgery and the importance
to her of very small differences in outcome should be major
factors in the decision-making process. However, these things
are often difficult for a physician to assess or a patient
to articulate in the emotionally charged atmosphere surrounding
a new cancer diagnosis.
We
have used the technique of decision analysis to develop a
model that predicts which treatment a patient should prefer
based on her answer to a series of questions. Some of these
questions are directly related to DCIS treatment issues, while
others address general attitudes toward risk. For the initial
testing of this model, we propose to study 90 women who have
already been treated for DCIS.
WE
WILL DETERMINE:
- If the model predicts the treatment they actually chose.
- Their perception of and satisfaction with the involvement
in the treatment decision-making process.
- Whether the model would be useful to women making a decision
about DCIS treatment.
Results
obtained from this study will allow us to refine the model
prior to testing its use in women with newly diagnosed DCIS
and will provide important information about patient priorities
in the treatment of this condition.
For
further information please contact Simbi Acharya at 312.926.9930
or s-acharya@northwestern.edu
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NU
95B2 STUDY: DOES TAMOXIFEN PREVENT THE SKELETAL AND CARDIOVASCULAR
MORBIDITY OF CHEMOTHERAPY IN PREMENOPAUSAL WOMEN?
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Chemotherapy
results in premature menopause for the majority of young women
who receive it. Estrogen replacement is not routinely given
to women with breast cancer due to concerns that it will stimulate
tumor growth. Women made prematurely menopausal are at increased
risk for the development of cardiovascular disease and osteoporosis.
Tamoxifen has been shown to protect menopausal women with
breast cancer from these conditions, but its effects in premenopausal
women are poorly studied. This study will compare blood cholesterol
levels and bone density in premenopausal women receiving chemotherapy
alone and those receiving chemotherapy plus tamoxifen over
a period of two years.
PATIENTS
ARE ELIGIBLE FOR THIS STUDY IF THEY ARE:
- Newly diagnosed breast cancer patients
- Premenopausal
- Never had chemotherapy before
- Have stage I or II breast cancer
For
further information please contact Simbi Acharya at 312.926.9930
or s-acharya@northwestern.edu
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NSABP
P2: STAR (STUDY OF TAMOXIFEN AND RALOXIFENE)
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The
Study of Tamoxifen and Raloxifene, or STAR, the largest breast
cancer prevention study in history, is recruiting volunteers
at more than 400 centers across the United States, Canada
and Puerto Rico. The trial will include 22,000 postmenopausal
women at increased risk for breast cancer to determine whether
the osteoporosis prevention drug raloxifene (Evista®)
isas effective in reducing the incidence of breast cancer
as tamoxifen (Nolvadex®) has proven to be. STAR is a study
of the National Surgical Adjuvant Breast and Bowel Project
(NSABP) and is supported by the National Cancer Institute
(NCI).
Tamoxifen
was shown to reduce the chance of developing breast cancer
by about 50% in the Breast Cancer Prevention Trial (BCPT),
a study of over 13,000 pre- and postmenopausal women at high
risk of breast cancer. Participants taking tamoxifen also
had fewer fractures of the wrist, hip and spine. The FDA approved
tamoxifen to reduce the incidence of breast cancer in women
at increased risk of the disease in October 1998. Raloxifene
was approved in December 1997 to prevent osteoporosis and
has been in clinical trials for about seven years. Raloxifene
has shown a breast cancer risk reduction similar to that of
tamoxifen but has not yet been tested in high-risk women.
Both drugs are known to increase the risk of blood clots in
large veins and the lungs. Tamoxifen increases risk of endometrial
cancer; to date, raloxifene has not demonstrated this effect.
An important part of STAR will be to compare the long-term
safety of both drugs.
Women
who participate in STAR must be at least 35 years old, postmenopausal
and have an increased risk of breast cancer as determined
by their age, family history and other risk factors. Potential
volunteers will receive a free breast cancer risk assessment.
If they are determined to be at high risk and decide to participate
in the study, patients will be randomly assigned to receive
either 20 mg tamoxifen or 60 mg raloxifene daily for five
years. All participants will have regular follow-up examinations,
blood tests, mammograms and gynecologic examinations. The
study drug is provided free of charge.
ADDITIONAL
CRITERIA INCLUDE:
- Not currently pregnant or within the past 12 months
- Has not lactated within the prior 12 months
- No chemotherapy within the past six months
- Never taken tamoxifen or raloxifene
- No active infection in the breast to be studied
- No known allergy to lidocaine, prilocaine, bupivacaine
or iodine
For
further information please contact Jennifer Clauson at 312.926.3407
or j-clauson@northwestern.edu
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THE
DIET AND HORMONE STUDY II (EFFECT OF SOY ON BREAST TISSUE)
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Funded
by the American Cancer Society, this six-month study will
measure whether consuming a soy product that contains phytoestrogens
will result in slower, more controlled growth of cells in
breast tissue.
PATIENTS
MUST MEET THE FOLLOWING CRITERIA TO BE ELIGIBLE:
- A woman with a personal history of breast cancer, a high-risk
breast lump or a close relative (mother, sister or daughter)
with breast cancer
- 30-60 years old
- Not pregnant
- Not taking oral contraceptives or hormone drugs
- Not allergic to soy
PARTICIPANTS
WILL:
- Attend three clinical visits
- Report food intake
- Provide blood, breast fluid (via suction) and breast cells
(obtained by nipple duct lavage)
- Consume a soy supplement or placebo
For
further information, please contact Kim Thedford at 312.503.0026
or kjuhl@northwestern.edu.
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NCI00B9:
PHASE I/II TRIAL OF IN VIVO ANGIOSTATIN GENERATION WITH TISSUE
PLASMINOGEN ACTIVATOR (tPA) AND CAPTOPRIL IN PATIENTS WITH
PROGRESSIVE, METASTATIC BREAST CANCER
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Angiostatin
and endostatin are two compounds which appear to act as potent
antiangiogenic agents. Though these compounds appear to have
antiangiogenic activity in a number of preclinical cell line
and animal model systems, it has been difficult to manufacture
them. Angiostatin is a multidomain protein containing up to
five kringle domains linked by cystein bridges. Ongoing studies
suggest that different kringle domains are important in mediating
the antiangiogenic activity of angiostatin. Dr Gerald Soff
has shown that angiostatin can be generated in vivo. Plasmin
contains five kringle domains. Proteolysis cleaves off a small
portion of kringle 5 thus generating the active antiangiogenic
angiostatin. Autoproteolysis was shown to be enhanced when
free sulfhydryl donors are present. Specifically in cell-free
systems, angiostatin was produced from human plasma after
treatment with tissue plasminogen activator (tPA) to degrade
plasminogen to plasmin in the presence of captopril.
This
Phase I/II trial is being funded by the National Cancer Institute
and is for patients with metastatic breast cancer. This protocol
will begin the scientific process of investigating the clinical
efficacy of these agents in breast cancer. More specifically,
it will be used to determine the toxicity of tPA plus the
free sulfhydryl donor captopril in patients with advanced
breast cancer.
PRIMARY
OBJECTIVE:
Assess
the toxicity of combining captopril with continuous infusion
tPA in patients with progressive, metastatic breast cancer.
Measure the in vivo generation of angiostatin by Western analysis.
SECONDARY
OBJECTIVE:
Assess
the antitumor effect of combining captopril with continuous
infusion tPA in patients with progressive, metastatic breast
cancer.
ELIGIBILITY
REQUIREMENTS FOR THIS STUDY INCLUDE BUT ARE NOT LIMITED TO:
- Progressive, metastatic breast cancer. Measurable disease
is not required
- Patients must have received at least one systemic treatment
for metastatic disease
- ECOG performance status of 0, 1 or 2
- Pretreatment granulocyte count of >=1500/mm3 and platelet
count of >=100,000/mm3
- Adequate renal function as documented by a serum creatinine
<=1.8 mg/dL
- Normal PT, aPTT and fibrinogen levels
- Adequate hepatic function as documented by a serum bilirubin
<=1.5 mg/dL, regardless of whether patients have liver
involvement secondary to tumor. Aspartate transaminase (SGOT)
must be <=3x institutional upper limit of normal. Serum
albumin must be normal
- >=4 weeks elapsed since completion of radiotherapy,
chemotherapy, biologic or endocrine therapy. Measurable
disease must be outside of a previously irradiated field
- No prior history of stroke, TIA or symptoms of cerebral
ischemia
- Cannot currently be receiving anticoagulation therapy
This will
be conducted as a dose-escalating trial of three dose levels
with at least three patients treated at each level. Study
treatment will be administered for five consecutive days.
Only one treatment cycle will be allowed in this pilot trial.
For
more information please contact Maggie Patton at 312.908.4048
or m-patton@northwestern.edu
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DRUG
OSI2288G: A PHASE II MULTICENTER, OPEN-LABEL CLINICAL TRIAL
TO EVALUATE THE EFFICACY AND SAFETY OF TARCEVA IN PATIENTS
WITH ADVANCED OR METASTATIC BREAST CANCER AND DISEASE PROGRESSION
DURING OR FOLLOWING CHEMOTHERAPY (AMENDMENT 2)
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Tarceva
(erlotinib) is an experimental selective inhibitor of the
epidermal growth factor receptor (EGFR) tyrosine kinase. The
EGFR is a protein found on the surface of many tumor cells
that may control tumor growth.
THE
STUDY WILL EVALUATE IF TARCEVA IS EFFECTIVE AND SAFE IN TWO
DIFFERENT SETS OF PATIENTS:
- Patients
with disease progression on or after treatment with an anthracycline,
a taxane and capecitabine
- Patients
with disease progression on or after therapy with at least
one chemotherapy regimen for locally advanced or metastatic
disease
All eligible patients will receive this oral (taken by mouth)
experimental study drug.
INCLUSION
CRITERIA INCLUDE BUT ARE NOT LIMITED TO:
- Histologically documented, incurable, locally advanced
or metastatic breast cancer
- Disease progression on or after therapy with an anthracycline,
a taxane and capecitabine, or with disease progression on
or after therapy with at least one chemotherapy regimen
for locally advanced or metastatic disease
- Measurable disease of ³2 cm (³1 cm on spiral
CT scan)
- ECOG performance status of 0 to 2
EXCLUSION
CRITERIA INCLUDE BUT ARE NOT LIMITED TO:
- Other primary malignancies within five years except for
adequately treate carcinoma in situ of the cervix or basal
or squamous cell skin cancer
- INR > 4.0 for patients receiving warfarin
- Symptomatic or untreated brain metastases
- Radiotherapy, immunotherapy, hormonal therapy or chemotherapy
within 21 days prior to Day 0 (six weeks for nitrosoureas
or mitomycin); prior therapy with an agent designed to target
either the EGFR or EGFR-specific tyrosine kinase activity
Approximately
200 women will participate in this study at approximately
40 centers in the United States. Patients will remain on study
until disease progression. Patients will be followed for survival
every two months thereafter.
For
more information please contact Maggie Patton at (312) 908-4048
or m-patton@northwestern.edu
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NCI00B11:
A PHASE II STUDY OF THE PROTEASOME INHIBITOR PS-341 (NSC 681
239) IN PATIENTS WITH METASTATIC BREAST CANCER
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The ubiquitin-proteasome
pathway plays an essential role in the degradation of most
short- and long-lived intracellular proteins in eukaryotic
cells. At the heart of this degradative pathway is the 26S
proteasome, an ATP-dependent, multicatalytic protease. Proteolytic
degradation of damaged, oxidized or misfolded proteins is
part of the housekeeping role for the 26S proteasome.
In addition, the 26S proteasome also plays a vital role in
degrading regulatory proteins that govern the cell cycle,
transcription factor activation, apoptosis and cell trafficking.
The ubiquitin-proteasome pathway also plays an important role
in regulating cell cycle, neoplastic growth and metastasis.PS-341
is a potent and reversible inhibitor of the ubiquitin-proteasome
pathway. The antineoplastic effects of PS-341 appear to result
from several distinct biological activities and have been
observed in a number of cellular assays. The results indicate
that PS-341 can inhibit cell growth, leading ultimately to
cytotoxicity by a mechanism involving apoptosis. Of interest
is the ability of PS-341 to induce apoptosis even in cells
that overexpress bcl2 and are resistant to other chemotherapeutics.
PS-341 also inhibits the degradation of p53, stabilizes the
CDK inhibitor p21 and inhibits the activation of NF-kB by
a mechanism involving the stabilization of the inhibitor protein
IkBa.
This is
a phase II clinical trial in patients with metastatic breast
cancer being supported by the NCI. Eligible patients are required
to have received one prior chemotherapy ( + Herceptin) treatment
for metastatic disease. Normal organ function is required
to participate.
PRIMARY
OBJECTIVE:
To determine
the objective tumor response in patients receiving PS-341.
SECONDARY
OBJECTIVES:
Estimation
of the progression-free survival of patients receiving PS-341,
evaluation of toxicities related to PS-341 and correlative
laboratory studies to assess the activity of PS-341 in individual
patients.
ELIGIBILITY
REQUIREMENTS FOR THIS STUDY INCLUDE BUT ARE NOT LIMITED TO:
- Patients must have histologically confirmed adenocarcinoma
of the breast that is metastatic. Measurable disease is
required
- May have received prior hormonal therapy for metastatic
disease
- One chemotherapy regimen (Herceptin) for metastatic disease
is required. Patients relapsing while receiving or within
six months of completing adjuvant chemotherapy will be considered
to have failed one regimen for metastatic disease.
- Patients must have normal organ and bone marrow function
- Patients with known brain metastases are excluded
PS-341
will be administered twice weekly, intravenously, for two
weeks followed by a one-week break (three-week cycle)
For
more information please contact Maggie Patton at (312) 908-4048
or m-patton@northwestern.edu
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