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Triple Negative Trial: A Randomised Phase III Trial of Carboplatin Compared to Docetaxel for Patients With Metastatic or Recurrent Locally Advanced ER-, PR- and HER2- Breast Cancer.


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Triple Negative Trial: A Randomised Phase III Trial of Carboplatin Compared to Docetaxel for Patients With Metastatic or Recurrent Locally Advanced ER-, PR- and HER2- Breast Cancer.


Inclusion Criteria:



- Histologically confirmed ER-, PR-, primary breast cancer

- Histologically confirmed HER2- primary breast cancer

- Measurable confirmed metastatic or recurrent locally advanced disease unsuitable for
local therapy but suitable for taxane chemotherapy

- Patients with stable, treated bain metastases will be eligible providing informed
consent can be given and that other sites of measurable disease are present.

- Patients with bone metastases currently receiving bisphosphonates for palliation will
be eligible providing informed consent can be given and that other sites of
measurable disease are present

- ECOG Performance Status 0, 1, or 2

- Adequate haematology, biochemical indices (FBC, U & Es)

- LFTs = Normal bilirubin, AST and/or ALT = 3 x ULN if Alk Phos >5 x ULN (or an
isolated elevation AST/ALT of ≤5 x ULN

- Adequate renal function - Creatinine clearance of >25mls per minute

- Written informed consent, able to comply with treatment and follow up

Exclusion Criteria:

- Original primary tumour or subsequent relapse known to be positive for any of ER, PR,
or HER2 receptors

- Patients unfit for chemotherapy or those with neuropathy >grade 1 (sensory or motor)

- Known allergy to platinum compounds or to mannitol

- Known sensitivity to taxanes

- Patients with inoperable locally advanced disease suitable for local radiotherapy or
an anthracycline containing regimen

- Previous chemotherapy for metastatic disease other than an anthracycline as in
inclusion criteria above

- Previous exposure to a taxane in adjuvant chemotherapy within 12 months of trial
entry

- Previous treatment with a taxane for recurrent locally advanced disease

- Previous treatment with a platinum chemotherapy drug

- LFTs = Abnormal bilirubin (> ULN), AST and/or ALT >3 X ULN and Alk Phos >5 x ULN (or
an isolated elevation AST/ALT of >5 x ULN)

- Patients with a life expectancy of less than 3 months

- Previous malignancies other than adequately treated in situ carcinoma of the uterine
cervix or basal or squamous call carcinoma of the skin, unless there has been a
disease free interval of at least 10 years

- Previous or synchronous second breast cancer (unless also confirmed ER-, PR- and
HER2-)

- Patients with bone limited disease

- Other serious uncontrolled medical conditions or concurrent medical illness likely to
compromise life expectancy and/or the completion of trial therapy

- Pregnant, lactating or potentially childbearing women not using adequate
contraception

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response: Response will be evaluated after three and six cycles of chemotherapy using modified Response Evaluation Criteria in Solid Tumours (RECIST) criteria, with appropriate clinical assessment and radiological investigations.

Principal Investigator

Andrew Tutt, MB ChB, MRCP, FRCR, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

King's College London

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

ICR-CTSU/2006/10003

NCT ID:

NCT00532727

Start Date:

January 2008

Completion Date:

July 2015

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Triple Negative
  • Breast Neoplasms

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