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

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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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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