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View Clinical Trial (Medical Research Study)
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Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial) - NCT00310180-54601B (Clinical Trial 140498)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy140498.aspx
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| City: |
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La Crosse |
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State:
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WI |
| Zip Code: |
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54601 |
| Conditions: |
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Breast Cancer |
| Purpose: |
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RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy may fight
breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount
of estrogen the body makes. 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. Giving
hormone therapy together with more than one chemotherapy drug (combination chemotherapy) has
been shown to reduce the chance of breast cancer recurrence, but the benefit of adding
chemotherapy to hormone therapy for women with node-negative, estrogen-receptor positive
breast cancer is small. New tests may provide information about which patients are more
likely to benefit from chemotherapy.
PURPOSE: This randomized phase III trial is trying to find out the best individual therapy
for women who have node-negative, estrogen-receptor positive breast cancer by using a
special test (Oncotype DX), and whether hormone therapy alone or hormone therapy together
with combination chemotherapy is better for women who have an Oncotype DX recurrence score
of 11-25.
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| Study summary: |
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OBJECTIVES:
Primary
- Compare the disease-free survival of women with previously resected axillary-node
negative breast cancer with an Oncotype DX Recurrence Score (ODRS) of 11-25 treated
with adjuvant combination chemotherapy and hormonal therapy vs adjuvant hormonal
therapy alone.
- Compare the distant recurrence-free interval, recurrence-free interval, and overall
survival of patients with an ODRS of 11-25 treated with these regimens.
- Create a tissue and specimen bank that includes formalin-fixed, paraffin-embedded tumor
specimens, tissue microarrays, plasma, and DNA obtained from peripheral blood of
patients enrolled in this trial.
Secondary
- Determine if adjuvant hormonal therapy alone is sufficient treatment (i.e., 10-year
distant disease-free survival of at least 95%) for patients with an ODRS of ≤ 10.
- Determine the disease-free survival, distant recurrence-free interval, recurrence-free
interval, and overall survival of patients with ODRS of ≤ 10.
- Compare the outcomes projected at 10 years using classical pathologic information,
including tumor size, hormone receptor status, and histologic grade, with those made by
the Genomic Health Oncotype DX test in patients treated with these regimens.
- Estimate failure rates as a function of ODRS separately in patients treated with
combination chemotherapy (group 2/arm II and group 3) and in patients treated with no
chemotherapy (group 1 and group 2/arm I).
- Determine the prognostic significance of the ODRS and of the individual recurrent score
gene groups (proliferation gene group, HER2 gene group, estrogen receptor gene group,
invasion gene group, and other genes) in patients treated with these regimens.
Tertiary
- To evaluate the effects of chemotherapy and hormonal therapy vs hormonal therapy alone
on perceived cognitive impairment, fatigue, fear of recurrence among pre-menopausal
patients, endocrine symptoms and sexual dysfunction, and overall health-related quality
of life (HRQL).
- To determine whether perceived cognitive impairment, fatigue, fear of recurrence,
endocrine symptoms, and overall HRQL are similar for patients receiving chemotherapy
plus hormonal therapy in secondary study group 2 as for those in the primary study
group (arm D vs C).
- To determine whether perceived cognitive impairment, fatigue, fear of recurrence,
endocrine symptoms, and overall HRQL are similar for patients receiving hormonal
therapy alone in secondary study group 1 as for those in the primary study group (arms
A vs B).
- To determine whether age will be inversely associated with a fear of recurrence,
independent of treatment assignment.
- Among participants receiving hormonal treatment alone on arm A and arm B, to determine
whether ODRS will be inversely correlated with fear of recurrence.
OUTLINE: This is a multicenter, partially randomized study. Patients are assigned to 1 of 3
treatment groups based on their risk of distant recurrence determined by Oncotype DX Breast
Cancer Assay.
- Group 1 (Secondary study group 1; Oncotype DX recurrence score [ODRS] < 11): Patients
receive standard hormonal therapy (e.g., oral tamoxifen alone, oral aromatase inhibitor
[e.g., anastrozole, letrozole, or exemestane] alone, or oral tamoxifen followed by oral
aromatase inhibitor) at the discretion of the treating physician for 5 or 10 years.
- Group 2 (Primary study group; ODRS 11-25): Patients are stratified according to tumor
size (≤ 2.0 cm vs ≥ 2.1 cm), menopausal status (postmenopausal vs premenopausal vs
perimenopausal), planned chemotherapy (taxane-containing [i.e., paclitaxel, docetaxel]
vs nontaxane-containing), planned radiotherapy (whole breast with no boost planned vs
whole breast with boost planned vs partial breast irradiation planned vs no planned
radiation therapy [for patients who have had a mastectomy]) and Oncotype DX Recurrence
Score (11-15 vs 16-20 vs 21-25). Patients are then randomized to receive either
hormonal therapy alone or combination chemotherapy and hormonal therapy.
- Arm I (experimental): Patients receive hormonal therapy as in group 1 at the
discretion of the treating physician.
- Arm II (standard): Patients receive standard combination chemotherapy at the
discretion of the treating physician. Within 4 weeks after the last dose of
chemotherapy, patients receive hormonal therapy as in group 1 at the discretion of
the treating physician.
- Group 3 (Secondary study group 2; ODRS > 25): Patients receive combination chemotherapy
as in group 2, arm II followed by hormonal therapy as in group 1.
Patients in all groups who have had breast-conservation surgery are also treated with
radiotherapy. Radiotherapy should begin within 4 weeks of registration for patients
receiving hormonal therapy alone or within 8 weeks after completion of chemotherapy.
Patients participating in NSABP and/or RTOG partial irradiation trial(s) may receive partial
breast radiation.
Tissue obtained at surgery (performed prior to study entry) is examined by the Oncotype DX
Recurrence Score Assay and other assays to correlate response with various biomarkers.
Patients may complete quality-of-life assessments at baseline and at 3, 6, 12, 24, and 36
months.
After completion of study treatment, patients are followed up periodically for up to 20
years.
PROJECTED ACCRUAL: A total of 11,248 patients will be accrued for this study. |
| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the breast
- Hormone receptor status: estrogen and/or progesterone receptor positive tumor
- Her2/neu negative tumor by either fluorescent in situ hybridization (FISH) or
immunohistochemistry (e.g., 0 or 1+ by DAKO Herceptest)
- Must have undergone surgery to remove the primary tumor by either a mastectomy or
local excision plus an acceptable axillary procedure (i.e., sentinel lymph node
biopsy and/or axillary dissection) within the past 84 days
- Must have adequate (i.e., ≥ 1 mm, if margin width specified) tumor-free margins
of resection for invasive and ductal carcinoma in situ
- Lobular carcinoma in situ involving the resection margins are allowed
- Negative axillary nodes as determined by a sentinel lymph node biopsy and/or
axillary dissection as defined by the American Joint Committee on Cancer sixth
edition staging system
- Tumor size 1.1-5.0 cm
- Tumors that measure 5 mm-1.0 cm are allowed provided there are unfavorable
histological features, defined as intermediate or poor nuclear and/or histologic
grade or lymphovascular invasion
- Pathologic tumor size should be used
- If microscopic measurement is used and tumor includes ductal carcinoma in
situ, the measurement should include only the invasive component of the
tumor
- Tissue specimen from the primary tumor available for diagnostic testing with Oncotype
DX to determine Oncotype Recurrence Score
- No prior Oncotype DX Assay unless patient has a recurrence score of 11-25
- Patients who develop breast cancer while receiving a selective estrogen-receptor
modulator (SERM) (e.g., tamoxifen, toremifene, or raloxifene) or an aromatase
inhibitor (e.g., anastrazole, letrozole, or exemestane) for breast cancer prevention
or a SERM for other indications (e.g., raloxifene for osteoporosis) are ineligible
- No prior ipsilateral or contralateral invasive breast cancer, bilateral synchronous
cancers, or prior ipsilateral or contralateral ductal carcinoma in situ
PATIENT CHARACTERISTICS:
- Female only
- Any menopausal status allowed
- WBC count ≥ 3,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Creatinine ≤ 1.5 mg/dL
- AST ≤ 3 times upper limit of normal
- Life expectancy ≥ 10 years
- No chronic obstructive pulmonary disease requiring treatment
- No chronic liver disease (e.g., cirrhosis or chronic active hepatitis)
- No history of cerebrovascular accident
- No history of congestive heart failure or other cardiac disease that would contradict
the use of an anthracycline (e.g., doxorubicin hydrochloride or epirubicin)
- No chronic psychiatric condition or other condition that would preclude study
compliance
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective nonhormonal contraception (e.g., intrauterine
device, condoms, diaphragm, abstinence)
- No other invasive malignancies within the past 5 years except curatively treated
basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy or radiotherapy (including MammoSite^® brachytherapy
radiotherapy) for this cancer
- Prior SERM or aromatase inhibitor therapy that was administered for up to 8 weeks for
this cancer is allowed
- No concurrent radiotherapy with chemotherapy
- Concurrent enrollment on another CTSU study allowed provided patient is already
enrolled on ECOG-PACCT-1 and the treatment options in the other study are consistent
with PACCT-1-specified treatment assignment (i.e., chemohormonal therapy or hormonal
therapy alone) |
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| Study is available at: |
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Gundersen Lutheran Center for Cancer and Blood
La Crosse, WI 54601
United States
Primary Contact:
Clinical Trials Office - Gundersen Lutheran Cancer Center
Email: cancerctr@gundluth.org
Phone: 608-775-2385 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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