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AzTrials

Breast CancerPhase 2NCT00343512

Docetaxel Followed by Surgery in Treating Women With Stage II or Stage III Breast Cancer

A Phase 2 study testing docetaxel, protein expression analysis and laboratory biomarker analysis in people with Breast Cancer, run by Vanderbilt-Ingram Cancer Center at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

RATIONALE: Dose-dense scheduling with (peg)filgrastim support may improve the clinical and pathologic complete response rate (pCR) and safety profile of single agent neoadjuvant docetaxel therapy. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
docetaxel, protein expression analysis and laboratory biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
2 sitesUnited States
Study dates
Feb 2004to Mar 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed invasive carcinoma of the breast by core biopsy
  • Tumor ≥ 2 cm in greatest dimension(may be either node positive or node negative disease
  • Patients with non-metastatic breast cancer who are in the judgment of the treating medical oncologist considered to be of sufficiently high risk to warrant adjuvant chemotherapy
  • Patients with internal mammary, supraclavicular and/or axillary node involvement are eligible. Patients with inflammatory breast cancer are eligible
  • Patients with T0 disease but palpable and measurable adenopathy are eligible for this trial. All sites of disease should be noted and followed
  • Hormone receptor status:
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  • Not specified
  • PATIENT CHARACTERISTICS:
  • ECOG performance status 0-1
  • Menopausal status not specified
  • Female ≥ 18 years old
  • Absolute neutrophil count ≥ 1,000/mm^3
  • Hemoglobin ≥ 8 g/dL
  • Platelet count ≥ 100,000/mm^3
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin normal
  • Alkaline phosphatase (AP), AST, and ALT meeting 1 of the following criteria:
  • AP normal AND AST or ALT ≤ 5 times ULN
  • AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
  • AP ≤ 5 times ULN AND AST or ALT normal
  • Women of child-bearing potential, must have a negative serum pregnancy test and must use effective contraception for the duration of the study and for at least 6 months after completion of study treatment
  • Patients with prior malignancies are eligible if they have been disease free for ≥ 5 years. Patients with curative treatment of non-melanomatous skin cancer, carcinoma in situ of the cervix, contralateral DCIS treated with mastectomy are eligible even if it is diagnosed in < 5 years.
  • PRIOR CONCURRENT THERAPY:
  • No prior anthracycline or taxane-based chemotherapy. Patients who received chemoprevention are eligible if the chemopreventive agent has been discontinued for at least one year prior to enrollment in the current study.
  • At least 1 year since prior tamoxifen for breast cancer prevention

Who cannot join

  • Prior radiotherapy to the ipsilateral breast
  • Patients who have had radiation to the contralateral breast are eligible
  • Evidence of distant metastatic disease (i.e., lung, liver, bone, brain)
  • Pregnant of breastfeeding
  • Patients who have congestive heart failure, angina pectoris, uncontrolled cardiac arrhythmia, or other significant heart disease, or who have had a myocardial infarction within the past year
  • Patients with > grade 1 peripheral neuropathy
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  • Patients with a history of hypersensitivity reaction to products containing polysorbate 80 (Tween 80)
  • Patients receiving an investigational anticancer drug within 3 weeks of registration
  • Patients with serious medical illness that in the judgment of the treating physician, places the patient at risk.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Meharry Medical College

    Nashville, Tennessee, 37208

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838

Other trials in United States

About this study

Official title: Pilot Study of Neoadjuvant Dose Dense Docetaxel With Correlative Molecular Studies in Stage II/III Breast Cancer

RATIONALE: Dose-dense scheduling with (peg)filgrastim support may improve the clinical and pathologic complete response rate (pCR) and safety profile of single agent neoadjuvant docetaxel therapy.

PURPOSE: To evaluate whether dose-dense scheduling with (peg)filgrastim support may improve the clinical and pathologic complete response rate (pCR) and safety profile of single agent neoadjuvant docetaxel therapy. To determine the changes in molecular markers that occurs with single agent docetaxel, tissue will be obtained at the end of the four cycles of docetaxel (either by repeat biopsy or definitive surgery).

Read the detailed description

OBJECTIVES:

Primary

  • Pathologic complete response rate (pCR) of dose dense docetaxel in the neoadjuvant setting.

Secondary

  • Safety and toxic effects of this regimen in these patients.
  • Tumor response rate (as measured by ultrasound) in patients treated with this regimen.
  • Determine whether early changes in markers of cell cycle position, proliferation, or apoptosis correlate with pathologic complete response rate in these patients.
  • Determine whether the molecular profile that predicts for chemoresponsiveness also predicts for response to radiotherapy (as measured by local recurrence) in these patients.
  • Determine whether tumors that demonstrate the greatest degree of change in protein expression patterns from pre- to post-docetaxel treatment will also be those that are most sensitive to chemotherapy (as measured by pathologic response rate) in these patients.

OUTLINE: This is a nonrandomized, open-label, pilot study.

  • Tissue Collection: Patients undergo tumor core biopsy (6-8 cores) and blood collection prior to initiating neoadjuvant docetaxel.
  • Neoadjuvant docetaxel with hematopoietic support: Patients receive docetaxel IV over 1 hour on day 1. Patients also receive pegfilgrastim subcutaneously (SC) on day 1 or 2 of each course OR filgrastim (G-CSF) or sargramostim (GM-CSF) SC daily beginning between day 2-4 of each course and continuing until blood counts recover. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
  • Surgery: Within 4-6 weeks after completion of neoadjuvant docetaxel, patients undergo definitive surgery.

Patients undergo tumor biopsy and blood collection periodically for pharmacokinetic, genetic, and molecular biomarker correlative studies. Samples are examined for changes in p21 protein expression (and/or p21 phosphorylation) and the protein expression profile.

After completion of study treatment, patients are followed at least every 6 months for 3 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Conditions
Breast Cancer
Being tested
docetaxel, protein expression analysis, laboratory biomarker analysis, biopsy, conventional surgery
Keywords
inflammatory breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
Medical subject headings
Breast Neoplasms, Inflammatory Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • docetaxelDrug

    Also called Taxotere

    Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles

  • protein expression analysisGenetic

    protein expression analysis

  • laboratory biomarker analysisOther

    laboratory biomarker analysis

  • biopsyProcedure or surgery

    biopsy

  • conventional surgeryProcedure or surgery

    conventional surgery

  • neoadjuvant therapyProcedure or surgery

    neoadjuvant therapy

Study groups in NCT00343512
Study groupRoleWhat they receive
Therapeutic InterventionExperimentalNot described
Receives: Drug: docetaxel; Genetic: protein expression analysis; Other: laboratory biomarker analysis; Procedure: biopsy; Procedure: conventional surgery; Procedure: neoadjuvant therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number Participants to Achieve Pathologic Complete Response

    whether or not patient has pathologic complete response (pCR) to dose dense docetaxel in the neoadjuvant setting (pCR = no residual viable tumor on histologic analysis)

    Measured: 3 month

Secondary outcomes (2)

  1. Safety Profile Based on Number of Patients With Each Worst-grade Toxicity

    Not all participants necessarily have an adverse event, thus not everyone will be accounted for in worst-grade toxicities. Likewise, one participant can potentially have more than one event in various grades 1-5 which accounts for the difference in number of patients analyzed and total number in the worst-grade toxicity tables. Tables represent the number of patients with worst-grade toxicity at each of five grades (grade 1, least severe; to grade 5, most severe) following NCI Common Toxicity Criteria

    Measured: Through 30 days after completion of treatment

  2. Tumor Response as Measured by Ultrasound

    Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.

    Measured: At screening, 8 weeks and at surgery (within 14-21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2006 (estimated)
  2. Study startFeb 2004
  3. Primary completionMar 2008
  4. Study completionMar 2011

Why it stopped: closed due to competing neoadjuvant studies for a small patient population

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00343512
Sponsor's protocol ID
VICC BRE 0368
Other IDs
VICC-BRE-0368, VICC-11239
Status last verified
Apr 2012
First submitted
22 Jun 2006
Last updated
27 Apr 2012
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing docetaxel, protein expression analysis and laboratory biomarker analysis in people with Breast Cancer, run by Vanderbilt-Ingram Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number Participants to Achieve Pathologic Complete Response (time frame: 3 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00343512.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2012.

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