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Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment: The TAILORx Trial

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Trial Conditions
  • Breast Cancer
  • Estrogen Receptor-positive Breast Cancer
  • HER2-negative Breast Cancer
  • Progesterone Receptor-positive Breast Cancer
  • Stage IA Breast Cancer
  • Stage IB Breast Cancer
  • Stage II Breast Cancer
  • Stage IIA Breast Cancer
  • Stage IIB Breast Cancer
  • Stage IIIB Breast Cancer
What is the purpose of this trial?

This randomized phase III trial studies 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. 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, by stopping them from dividing, or by stopping them from spreading. 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.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
18  - 75 

Gender:
Female

Eligibility

Inclusion Criteria:

- Patients with operable histologically confirmed adenocarcinoma of the female breast
who have completed primary surgical treatment and meet the following criteria:

- ER and/or progesterone receptor (PR)-positive: Estrogen and/or progesterone
receptor positive disease (as defined by local pathology laboratory)

- Negative axillary nodes: As assessed by a sentinel lymph node biopsy, an
axillary dissection, or both, and as defined by the Sixth Edition of the
American Joint Committee on Cancer (AJCC) staging criteria

- Tumor size 1.1-5.0 cm (or 5 mm-1.0 cm plus unfavorable histological features):

- Unfavorable features defined as intermediate or poor nuclear and/or
histologic grade, or lymphovascular invasion

- NOTE: Definition of tumor size: The tumor size used for determination of
eligibility is the pathologic tumor size, which is usually determined by
the size of the tumor as measured by inspection of the gross specimen; if
the tumor size is measured microscopically and the tumor includes ductal
carcinoma in-situ, the measurement should include only the invasive
component of the tumor

- The tumor must be human epidermal growth factor receptor 2 (Her2)/neu negative
by either fluorescent in-situ hybridization (FISH) or immunohistochemistry (e.g.
0 or 1+ by DAKO Herceptest)

- The patient and physician must be agreeable to initiate standard chemotherapy and
hormonal therapy as adjuvant therapy

- A tissue specimen from the primary breast cancer has been located and is ready to be
shipped to the appropriate laboratory after consent is obtained and within 3 days
following pre-registration; NOTE: For determination of the Oncotype Recurrence Score,
tissue must be shipped to Genomic Health; if the Oncotype DX Recurrence Score was
previously performed by Genomic Health (prior to pre-registration), tissue must be
submitted to the Eastern Cooperative Oncology Group (ECOG)-American College of
Radiology Imaging Network (ACRIN) Pathology Coordinating Office upon randomization

- Leukocyte count >= 3500/mm^3

- Platelets >= 100,000/mm^3

- Serum creatinine =< 1.5 mg/dL

- Serum aspartate transaminase (AST) that is =< 3-fold the upper institutional limits
of normal

- Patients must be disease-free of prior invasive malignancies for >= 5 years with the
exception of curatively-treated basal cell or squamous cell carcinoma of the skin or
carcinoma in situ of the cervix; patients with a previous ipsilateral or
contralateral invasive breast cancer, or with bilateral synchronous cancers, are not
eligible; patients with previous ipsilateral or contralateral ductal in situ
carcinoma (DCIS) are not eligible

- Prior treatment

- Mandatory prior surgery criteria:

- Patient must pre-register within 84 days from the final surgical procedure
required to adequately treat the primary tumor (please note that if margins
are not clear and a resection has to be conducted after pre-registration
but before randomization, the patient will be deemed to be within the 84
day window allowed by protocol and therefore eligible)

- All tumors should be removed by either a mastectomy or local excision plus
an acceptable axillary procedure (i.e., sentinel lymph node biopsy,
axillary dissection, or both); there must be adequate (at least 1 mm if
margin width specified) tumor-free margins of resection (for invasive and
ductal carcinoma in-situ) in order for the patients to be eligible;
patients with lobular carcinoma in-situ involving the resection margins are
eligible

- Criteria re: other prior treatments:

- No prior chemotherapy for this malignancy

- No prior radiation therapy for this malignancy; this includes no prior
MammoSite Brachytherapy radiation therapy (RT)

- Hormonal therapy: Patients who develop breast cancer while receiving a
selective estrogen-receptor modulator (SERM; e.g., tamoxifen, toremifene,
raloxifene) or an aromatase inhibitor (e.g., anastrazole, letrozole,
exemestane) for breast cancer prevention or a SERM for other indications
(e.g., raloxifene for osteoporosis) are not eligible; however, patients may
have received up to 8 weeks of a SERM or aromatase inhibitor for this
malignancy and still be eligible for study entry

- Patients must have an anticipated life expectancy of at least 10 years

- Patients with the following medical conditions should not be enrolled on the study:

- Chronic obstructive pulmonary disease requiring treatment

- Chronic liver disease (e.g., cirrhosis, chronic active hepatitis)

- Previous history of a cerebrovascular accident

- History of congestive heart failure or other cardiac disease that would
represent a contraindication to the use of an anthracycline (e.g., doxorubicin
or epirubicin)

- Chronic psychiatric condition or other condition that would impair compliance
with the treatment regimen

- Women must not be pregnant or breast-feeding; all females of childbearing potential
must have a blood test or urine study within 2 weeks prior to pre-registration to
rule out pregnancy

- Women of childbearing potential must be strongly advised to utilize an accepted
and effective form of non-hormonal contraception (e.g. intrauterine device,
condoms, diaphragm, abstinence)

- Patients must not have previously had the Oncotype DX Assay performed, with the
exception of patients who have had the assay performed and have a recurrence score of
11-25

Gender: Female
Steward Physician(s)
  • Joseph Sparano
  • Daniel F. Hayes, MD
  • Elizabeth C. Dees, MD
  • John A. Olson, MD, PhD
  • Edith A. Perez, MD
  • Kathleen I. Pritchard, MD
  • Charles E. Geyer, FACP, MD
Facilities
  • St. Elizabeth's Medical Center - Active, not recruiting
Trial Interventions
Drug
  • tamoxifen citrate
  • anastrozole
  • letrozole
  • exemestane
Other
  • laboratory biomarker analysis
  • quality-of-life assessment
Radiation
  • radiation therapy
Physician Researcher

Investigator Name:

  • Joseph Sparano
  • Daniel F. Hayes, MD
  • Elizabeth C. Dees, MD
  • John A. Olson, MD, PhD
  • Edith A. Perez, MD
  • Kathleen I. Pritchard, MD
  • Charles E. Geyer, FACP, MD

Other Information

Sponsor: National Cancer Institute (NCI)
Phase: Phase 3
Trial ID: NCT00310180
Volunteers:  Not Accepting Healthy Volunteers

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