AzTrials
AzTrials

Breast CancerPhase 3TNTNCT00532727

Triple Negative Breast Cancer Trial

A Phase 3 study testing Carboplatin and Docetaxel in people with Breast Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether there is greater activity for carboplatin than a taxane standard of care (docetaxel) in women with ER-, PR- and HER2- breast cancer. The trial aims to recruit between 370 and 450 patients. 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?
Carboplatin and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteUnited Kingdom
Study dates
Jan 2008to Mar 2020
Phase
Phase 3
Are there results?
None posted in the registry

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 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Guy's and St Thomas' Hospital NHS Foundation Trust

    London, SE1 9RT

Other trials in United Kingdom

About this study

Official title: 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.

The purpose of this study is to determine whether there is greater activity for carboplatin than a taxane standard of care (docetaxel) in women with ER-, PR- and HER2- breast cancer. The trial aims to recruit between 370 and 450 patients.

Conditions
Breast Cancer
Being tested
Carboplatin, Docetaxel
Keywords
Breast Cancer, Triple Negative
Medical subject headings
Breast Neoplasms

What participants receive

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

  • CarboplatinDrug

    AUC 6 every 3 weeks for six cycles (18 weeks)

  • DocetaxelDrug

    100mg/m2 every 3 weeks for six cycles (18 weeks)

Study groups in NCT00532727
Study groupRoleWhat they receive
Arm AExperimentalCarboplatin
Receives: Drug: Carboplatin
Arm BActive comparatorDocetaxel
Receives: Drug: Docetaxel

What is being measured

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

  1. 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.

    Measured: Time from start of treatment to 18 weeks

Secondary outcomes (5)

  1. Time to progression: this will be defined according to RECIST criteria and will be measured from the start of treatment until the confirmation of progression

    Measured: Time from start of treatment until confirmation of progression

  2. Progression free survival: this will be defined according to RECIST criteria and will be measured from the start of treatment until the confirmation of progression or death.

    Measured: Time from start of treatment until confirmation of progression or death

  3. Time to treatment failure: this will be defined as time from randomisation to discontinuation of protocol treatment for any reason, or progression of disease as defined by RECIST

    Measured: Time from randomisation to discontinuation of protocol treatment for any reason, or progression of disease

  4. Overall survival: this will be defined as time from randomisation until death from any cause in the intention to treat population

    Measured: Time from randomisation until death from any cause

  5. Toxicity will be assessed throughout the treatment period using the National Cancer Institute Common Terminology Criteria for Adverse Events version three (NCI CTCAE v3.0)

    Measured: Time from start of treatment to 18 weeks

Timeline

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

  1. First posted20 Sep 2007 (estimated)
  2. Study startJan 2008
  3. Primary completionMar 2016
  4. Study completionMar 2020 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00532727
Sponsor's protocol ID
ICR-CTSU/2006/10003
Other IDs
ISRCTN97330959, Main REC: 07/Q0603/67, CTA: 22138/0004/001-0001, EudraCT Number: 2006-004470-26
Acronym
TNT
Status last verified
Feb 2019
First submitted
19 Sep 2007
Last updated
20 Feb 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Tutt A, Tovey H, Cheang MCU, Kernaghan S, Kilburn L, Gazinska P, Owen J, Abraham J, Barrett S, Barrett-Lee P, Brown R, Chan S, Dowsett M, Flanagan JM, Fox L, Grigoriadis A, Gutin A, Harper-Wynne C, Hatton MQ, Hoadley KA, Parikh J, Parker P, Perou CM, Roylance R, Shah V, Shaw A, Smith IE, Timms KM, Wardley AM, Wilson G, Gillett C, Lanchbury JS, Ashworth A, Rahman N, Harries M, Ellis P, Pinder SE, Bliss JM. Carboplatin in BRCA1/2-mutated and triple-negative breast cancer BRCAness subgroups: the TNT Trial. Nat Med. 2018 May;24(5):628-637. doi: 10.1038/s41591-018-0009-7. Epub 2018 Apr 30.

    PubMed 29713086

  • Tovey H, Sipos O, Parker JS, Hoadley KA, Quist J, Kernaghan S, Kilburn L, Salgado R, Loi S, Kennedy RD, Roxanis I, Gazinska P, Pinder SE, Bliss J, Perou CM, Haider S, Grigoriadis A, Tutt A, Cheang MCU. Integrated Multimodal Analyses of DNA Damage Response and Immune Markers as Predictors of Response in Metastatic Triple-Negative Breast Cancer in the TNT Trial (NCT00532727). Clin Cancer Res. 2023 Sep 15;29(18):3691-3705. doi: 10.1158/1078-0432.CCR-23-0370.

    PubMed 37574209

  • Sipos O, Tovey H, Quist J, Haider S, Nowinski S, Gazinska P, Kernaghan S, Toms C, Maguire S, Orr N, Linn SC, Owen J, Gillett C, Pinder SE, Bliss JM, Tutt A, Cheang MCU, Grigoriadis A. Assessment of structural chromosomal instability phenotypes as biomarkers of carboplatin response in triple negative breast cancer: the TNT trial. Ann Oncol. 2021 Jan;32(1):58-65. doi: 10.1016/j.annonc.2020.10.475. Epub 2020 Oct 21.

    PubMed 33098992

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Carboplatin and Docetaxel in people with Breast Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.

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 10 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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?

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. (time frame: Time from start of treatment to 18 weeks). 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 NCT00532727, which also lists 3 linked publications.

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 20 Feb 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in