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Completed

NCT Number: NCT03048942

Pilot Study of Cabazitaxel and Paclitaxel in HER2 Negative Breast Cancer

90 patients with HER2 negative breast cancer will be randomised to receive 18 weeks of chemotherapy treatment, either 6 cycles of 3 weekly Cabazitaxel or 6 cycles of weekly Paclitaxel to determine the difference in progression free survival between the 2 groups. If results at that stage suggest a potential benefit then the trial will be developed further to accrue 70 more patients.

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Key information

Conditions

HER2 Negative Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Royal United Hospital, Bath, United Kingdom

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About this study

This is a prospective multicentre, randomised, open label, study comparing the efficacy and the safety of six 3-weekly cycles cabazitaxel versus 18 x weekly paclitaxel given as first line chemotherapy treatment in patients with HER2-normal metastatic breast cancer. Randomisation will be conducted by a 1:1 ratio.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent
  • Metastatic breast cancer fit to receive cytotoxic chemotherapy for metastatic disease
  • Measurable disease as per RECIST 1.1
  • HER2 negative defined as ICH 0+, 1+ or 2+ and FISH/SISH/CISH(ration<2.0) in the case of IHC 2+
  • ECOG performance status 0 or 1
  • ER+ve or ER-ve
  • Female age ≥18 years
  • Anticipated life expectancy > 6 months
  • Haemoglobin >10.0g/DL
  • Absolute neutrophil count>1.5 x 10^9/L
  • Platelet count>100 x 10^9/L
  • ALT/SGPT<1.5 X ULN
  • Serum creatinine <1.5 x ULN
  • Negative pregnancy test for all women of child bearing potential

Exclusion criteria

  • Grade ≥2 oral mucositis or peripheral or sensory neuropathy
  • History of other malignancy
  • History of severe hypersensitivity ≥grade 3 to polysorbate 80- containing drugs and taxanes
  • Clinically significant cardiovascular disease
  • Any acute or chronic medical condition
  • Acute infection requiring systemic antibiotics or antifungal medication
  • Sex hormones
  • Administration of any live vaccine within 8 weeks
  • Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5
  • Participation in another clinical trial with an investigational drug within 30 days of randomisation
  • Pregnant or breast feeding women
  • Contraindications to the use of corticosteroid treatment
  • HER2 Positive breast cancer
  • Previous Paclitaxel chemotherapy in the adjuvant setting
  • Previous cytotoxic chemotherapy for metastatic disease
  • Palliative radiotherapy for metastatic disease within 4 weeks of randomisation
  • Symptomatic brain metastases confirmed with CT/MRI brain
  • History of other malignancy
  • Grade 2

Treatment and study plan

Cabazitaxel

Drug

3 weekly cyctotoxic chemotherapy

Other names: Jevtana

paclitaxel

Drug

Weekly cyctotoxic chemotherapy

Primary outcomes

  1. Progression Free Survival

    Time frame: Defined as the time from randomisation to either disease progression or death from any cause, whichever came first, assessed up to 5 years.

    Duration of progression free survival

Secondary outcomes

  1. Clinical Benefit Rate

    Time frame: At the completion of 6 cycles of chemotherapy, which is after 18 weeks

    Defined as stable disease rate + partial response rate+complete response rate according to RECIST 1.1 criteria

  2. Objective Response Rate

    Time frame: At completion of 6 cycles of chemotherapy, which is after 18 weeks.

    Objective response rate (ORR) is defined as complete response (CR) plus partial response (PR) as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan every 6 weeks. Tumours were assessed at baseline and compared to the response seen at the completion of treatment. Only responses seen within the 6 cycles of treatment e.g. up to and including the end of treatment tumour assessment are included in this measure.

    CR - Disappearance of all target lesions; PR >=30% decrease in the sum of the longest diameter of target lesions.

  3. Overall Survival

    Time frame: Determined as the time from randomisation to death from any cause. Average survival rates for this population may be approximately 18 months.

    Survival duration from randomisation to date of death.

  4. Time to Next Chemotherapy Treatment

    Time frame: Measured from from the date of the last day of trial treatment. approximately after progression which on average would be after 12 months.

    time from randomisation to another chemotherapy treatment after confirmed progression.

  5. Time to Response

    Time frame: Determined by time from randomisation to radiological partial response. This was sometimes seen after treatment end but all responses occurred by 8 months from randomisation therefore within 32 weeks.

    Time taken for tumour burden to respond to treatment

  6. Assessment of EQ-5D-5L Questionnaire

    Time frame: EQ5D-5L and FACT B will be completed at baseline, prior to cycle 3 (approximately Day 63), prior to cycle 5 (approximately Day 105) and at the end of treatment visit, (approximately 21 weeks)

    EQ-5D-5L will be assessed at baseline, prior to cycle 3 and cycle 5 and at the end of treatment. The patients answer 5 questions which have 5 possible answers from no issue to extreme issue. The answers are given a code, 1, 2, 3, 4 or 5 with 1 for no issue through to 5 for extreme issues which results in a 5 digit 'health state' for that time point. Using a formula this is translated into the 'EQ-5D index value' where 1 is full health and 0 is the worst health. This is what is presented here, the lower the score the worse the quality of life.

  7. Assessment of EQ-5D-5L VAS Score

    Time frame: EQ5D-5L and FACT B will be completed at baseline, prior to cycle 3 (approximately Day 63), prior to cycle 5 (approximately Day 105) and at the end of treatment visit, (approximately 21 weeks)

    EQ-5D-5L VAS score was assessed at baseline, prior to cycle 3 and 5 and at the end of treatment. Patients are asked to score their health on a scale 0-100, the higher the score the better they are feeling.

  8. Assessment of FACT-B Questionnaire

    Time frame: EQ5D-5L and FACT B will be completed at baseline, prior to cycle 3 (approximately Day 63), prior to cycle 5 (approximately Day 105) and at the end of treatment visit, (approximately 21 weeks)

    FACT-B will be assessed at baseline, prior to cycle 3 and cycle 5 and at the end of treatment. The patients answer 37 questions which have 5 possible answers from not at all to very much. The answers are given a code, 0, 1, 2, 3 or 4 with 0 for not at all through to 4 for very much. The scores are reversed and then totalled to give a value out of 148. This is what is presented here, the higher the score the better the quality of life.

Sponsors and collaborators

Lead sponsor

University Hospitals Bristol and Weston NHS Foundation Trust

Other

Registry information

Official study title

A Randomised Phase II Pilot Study of 3 Weekly Cabazitaxel Versus Weekly Paclitaxel Chemotherapy in the First Line Treatment of HER2 Negative Breast Cancer

Acronym: CONCEPT

Important dates

Study start
2014
Primary completion
2021
Study completion
2025
First posted
Feb 9, 2017
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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