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An Open-label, Randomised, Phase II Study of Docetaxel in Combination With a Dietary Phytonutrient in First or Second Line Treatment for Patients With HER2 Negative Locally Advanced or Metastatic Breast Cancer, or Loco-regional Recurrence Not Amenable to Treatment by Surgery or Radiotherapy.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

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Trial Information

An Open-label, Randomised, Phase II Study of Docetaxel in Combination With a Dietary Phytonutrient in First or Second Line Treatment for Patients With HER2 Negative Locally Advanced or Metastatic Breast Cancer, or Loco-regional Recurrence Not Amenable to Treatment by Surgery or Radiotherapy.


OBJECTIVES:

Primary

- To compare the response rate in HER2-negative patients with locally advanced or
metastatic breast cancer or locoregional breast cancer recurrence treated with
docetaxel and a dietary phytochemical vs docetaxel alone.

Secondary

- To compare the overall clinical benefit rate (i.e., objective response plus stable
disease) in patients treated with these regimens.

- To compare time to progression in patients treated with these regimens.

- To compare overall survival of patients treated with these regimens.

- To assess biomarkers of response in blood samples from patients treated with these
regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to recruitment
center and line of chemotherapy (first vs second line of docetaxel). Patients are randomized
to 1 of 2 treatment arms.

- Arm I: Patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 3
weeks for up to 6 courses in the absence of disease progression or unacceptable
toxicity.

- Arm II: Patients receive docetaxel as in arm I. Patients also receive an oral dietary
phytochemical twice on day 1. Treatment repeats every 3 weeks for up to 6 courses in
the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed adenocarcinoma of the breast, meeting 1 of
the following criteria:

- Locally advanced disease

- Documented metastatic disease without overexpression of Her2/neu

- Must have received prior anthracycline-containing regimen as neoadjuvant,
adjuvant, or first-line chemotherapy for metastatic breast cancer

- Loco-regional recurrence not amenable to treatment by surgery or radiotherapy

- At least one measurable lesion according to RECIST criteria

- No bone lesion only disease

- Must be a candidate for taxane-based chemotherapy

- HER2-negative disease

- No symptomatic brain metastases

- Hormone receptor status not specified

PATIENT CHARACTERISTICS:

- Menopausal status not specified

- WHO performance status 0-2

- Life expectancy ≥ 3 months

- ANC ≥ 2,000/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 10 g/dL

- Serum creatinine < 140 µmol/L OR creatinine clearance > 60 mL/min

- Total bilirubin ≤ upper limit of normal (ULN)

- AST and ALT ≤ 1.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No history of significant neurologic (i.e., peripheral neuropathy ≥ grade 2) or
psychiatric disorders, including psychotic disorders, dementia, or seizures that
would prohibit the understanding, observance, and giving of informed consent

- No other prior or concomitant malignancies except adequately treated carcinoma in
situ of the cervix uteri, basal cell or squamous cell carcinoma of the skin, or other
cancer curatively treated with surgery and/or radiotherapy

- No concurrent severe and/or uncontrolled co-morbid medical condition

- No medically unstable patients

- No uncontrolled infection

- No autoimmune disease and/or chronic active inflammation

- No psychological, familial, social, or geographical reasons that would make clinical
follow-up impossible

- No malabsorption syndrome or disease significantly affecting gastrointestinal
function

- No dysphagia ≥ grade 2

- No history of hypersensitivity to taxanes or known excipients, including polysorbate
80

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior major resection of the stomach or proximal small bowel

- Prior hormonal therapy as adjuvant treatment and/or treatment of metastatic disease
allowed provided that the patient has progressive disease at study entry

- Hormonal treatment must be discontinued prior to study entry

- No more than 1 prior chemotherapy regimen for metastatic disease

- More than 30 days since prior investigational drug

- More than 3 weeks since prior NSAIDs or COX_2 inhibitors

- No other concurrent anticancer therapy

- No other concurrent dietary phytonutrients

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate as assessed by RECIST criteria

Safety Issue:

No

Principal Investigator

Philippe Chollet, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Jean Perrin

Authority:

Unspecified

Study ID:

CDR0000635901

NCT ID:

NCT00852332

Start Date:

August 2009

Completion Date:

Related Keywords:

  • Breast Cancer
  • male breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • stage IIIA breast cancer
  • HER2-negative breast cancer
  • Breast Neoplasms

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