Pilot Study of Cabazitaxel and Paclitaxel in HER2 Negative Breast Cancer (CONCEPT)

U

University Hospitals Bristol and Weston NHS Foundation Trust

Status and phase

Enrolling
Phase 2

Conditions

HER2 Negative Metastatic Breast Cancer

Treatments

Drug: Paclitaxel
Drug: Cabazitaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT03048942
ON/2012/4234

Details and patient eligibility

About

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.

Full description

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.

Enrollment

160 estimated patients

Sex

Female

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

160 participants in 2 patient groups

Cabazitaxel
Experimental group
Description:
6 cycles of cabazitaxel intravenous chemotherapy 25mg/m2 on day 1 of each 21 day cycle
Treatment:
Drug: Cabazitaxel
Paclitaxel
Active Comparator group
Description:
6 cycles of Paclitaxel intravenous chemotherapy 80mg/m2 on days 1,8 and 15 of each 21 day cycle.
Treatment:
Drug: Paclitaxel

Trial contacts and locations

0

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Central trial contact

Alicia Bravo; Amit K Bahl

Data sourced from clinicaltrials.gov

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