8 Continuous vs 8 Intermittent Cycles in First and Second Line in HER2/Neu Neg Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

An open randomized phase III study to compare 8 continuous cycles of chemotherapy with 8 cycles of intermittent (2 times 4 cycles) chemotherapy in first line treatment, in combination with bevacizumab, and second line treatment of patients with HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Borstkanker Onderzoek Groep
• Collaborators: Roche Pharma AG; Teva Pharma
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Capecitabine; Doxorubicin; Liposomal doxorubicin; Paclitaxel

Criteria

Inclusion Criteria:

• Female patients ≥ 18 years old.

• Patients with HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer, who are candidates for chemotherapy.

• Patients with measurable or evaluable-only (RECIST 1.1)

• Documented Estrogen Receptor (ER) / Progesteron Receptor (PR) status.

• HER2/neu-negative disease

• Patients with an ECOG Performance Status ≤ 2.

• Life expectancy of > 12 weeks.

• Signature of Informed Consent Form

Exclusion Criteria:

• Previous chemotherapy for HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer.

• Prior hormonal therapy for HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer that has not been discontinued 1 week before start of study treatment.

• Prior adjuvant/neo-adjuvant chemotherapy within 6 months prior to first study treatment. However, if the prior adjuvant/neo-adjuvant chemotherapy was taxane based, patients are excluded if they received their last chemotherapy within12 months prior to first study treatment.

• Prior radiotherapy covering more than 30% of marrow-bearing bone.

• Patients that have received recent radiation therapy that are not recovered from any significant (Grade ≥ 3) acute toxicity prior to study treatment.

• Prior therapy with bevacizumab, sorafenib, sunitinib, or other VEGF pathway-targeted therapy.

• Chronic daily treatment with aspirin

• Chronic daily treatment with corticosteroids, with the exception of inhaled steroids.

• Current or recent treatment with another investigational drug or participation in another investigational study.

• Inadequate bone marrow, liver, renal function

• INR > 1.5 or an aPTT > 1.5 x ULN within 7 days prior to first study treatment.

• Known CNS disease, except for treated brain metastases.

• Patients with concurrent active malignancy

• Pregnant or lactating

• Women of childbearing potential not using effective, non-hormonal means of contraception

• Major surgical procedure (including open biopsy) within 28 days prior to the first study treatment

• Core biopsy or other minor surgical procedure, within 7 days prior to day 1.

• Significant vascular disease within 6 months prior to day 1.

• Any previous venous thrombo-embolism > CTC Grade 3.

• History of haemoptysis

• History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.

• Uncontrolled hypertension

• Clinically significant (i.e. active) cardiovasculair disease

• LVEF by MUGA or ECHO < 50%.

• History of abdominal fistula, Grade 4 bowel obstruction or GI perforation, intra-abdominal abscess within 6 months of randomization.

• Serious non-healing wound, peptic ulcer or bone fracture.

• Known hypersensitivity to any of the study drugs or excipients.

• Hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.

• Psychiatric illness, physical examination or laboratory findings that may interfer with protocol