Bevacizumab Plus Paclitaxel Optimization Study With Interventional Aintenance Endocrine Therapy in Breast Cancer

NCT ID: NCT01989780

Last Updated: 2022-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2019-06-30

Brief Summary

To compare continuing bevacizumab + paclitaxel or switching to bevacizumab + endocrine maintenance therapy followed by bevacizumab + paclitaxel, after 1st line induction therapy with bevacizumab + paclitaxel in ER+HER2- advanced or metastatic breast cancer.

Detailed Description

This multicenter, randomized Phase II study of patients with advanced or metastatic estrogen receptor-positive human epidermal receptor type 2-negative breast cancer aims to compare two treatment strategies following induction therapy with 4-6 cycles of the combined use of weekly paclitaxel (wPTX) and bevacizumab (BV). In arm A, wPTX+BV is continued, while in arm B, wPTX is switched to maintenance endocrine therapy (hormone+BV) until disease progression, followed by wPTX+BV re-induction. The primary endpoint is time to failure of strategy, which is the time from randomization to a qualifying event (addition of a new agent not in the primary regimen, progressive disease during or after planned therapy, or death).

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

weekly paclitaxel + bevacizumab

Group Type: ACTIVE_COMPARATOR

Paclitaxel

Intervention Type: DRUG

Bevacizumab

Intervention Type: DRUG

Arm B

endocrine therapy* + bevacizumab then back to weekly paclitaxel + bevacizumab therapy

(*Letrozole, Anastrozole, Exemestane, Fulvestrant, LHRH Analogs + Aromatase inhibitors.)

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

Bevacizumab

Intervention Type: DRUG

Letrozole

Intervention Type: DRUG

Anastrozole

Intervention Type: DRUG

Exemestane

Intervention Type: DRUG

Fulvestrant

Intervention Type: DRUG

Goserelin

Intervention Type: DRUG

leuprorelin

Intervention Type: DRUG

Interventions

Paclitaxel

Intervention Type: DRUG

Bevacizumab

Intervention Type: DRUG

Letrozole

Intervention Type: DRUG

Anastrozole

Intervention Type: DRUG

Exemestane

Intervention Type: DRUG

Fulvestrant

Intervention Type: DRUG

Goserelin

Intervention Type: DRUG

leuprorelin

Intervention Type: DRUG

Other Intervention Names

Taxol; Avastin; Femara; Arimidex; Aromasin; Faslodex; Zoladex; Leuplin

Eligibility Criteria

Inclusion Criteria

1. Histologically confirmed adenocarcinoma of the breast

2. Female aged 20-75 years old at getting informed consent

3. HER2 negative disease (IHC 0/1+ or 2+ with FISH negative)

4. Documented estrogen receptor (ER) positive (>=1% by IHC)

5. Inoperative locally advanced or metastatic breast cancer at enrolment

6. Performance status (ECOG): 0-1 at enrolment

7. Life expectancy of at least 3 months from enrolment

8. No prior systemic therapy for recurrent breast cancer (excluding hormone therapy)

9. No prior neo and/or adjuvant chemotherapy with taxane or adjuvant setting with a disease-free interval from completion of the taxane treatment to metastatic diagnosis of >= 12 months

10. Patients with measurable lesion regarding with Response Evaluation Criteria in Solid Tumors(RECIST) criteria or who have evaluable lesion

11. Patients with only bone lesion will be acceptable if the osteolytic lesion has a measurable soft tissue component by MRI or CT

12. No influence on protocol treatment is considered in case prior therapy or examination.

13. Adequate following organ function within 2 weeks before starting treatment. The latest examination results should be adopted and blood transfusion or treatment of hematopoietic factor drugs is not allowed 2 weeks before examination.

• Absolute neutrophil count >= 1500 /mm3 or white blood cell(WBC) count >= 3000 /mm3
• Platelets >=10 x 10000 /mm3
• Hb >= 9 g/dL
• Total bilirubin <= 1.5 mg/dL
• aspartate aminotransferase(AST) and alanine aminotransferase(ALT) <= 100 international unit(IU)/L
• Serum creatinine <= 1.5 mg/dL
• Urine dipstick for proteinuria <= 1+

14. Written informed consent signed by patients before completing any treatment related procedure

Exclusion Criteria

1. Prior therapy with bevacizumab

2. Active infection requiring intrvenous antibiotics at enrollment or infection with active HBV and/or HCV.

3. Pregnancy, lactetion or in case of potentialy pregnancy women Not mind contraception in trial period.

4. Known hypersensitivity to bevacizumab or paclitaxel

5. History of hemoptysis (>= 2.5mL of bright red blood per episord).

6. Use of disulfiram,cyanamide, carmofur or procarbazine Hydrochloride

7. Patients with CNS metastases (except for not symptomatic)

8. Persistent Grade >= 2 sensory neuropathy at enrollment

9. Grade 3 >= hypertension (>= 2 use of antihypertensive drug)

10. Evidence with arterial thromboembolism (Cerebral infarction, Myocardial infarction) or history within 1 year prior to enrollment.

11. Evidence withvenous thromboembolism (deep vein thrombosis, pulmonary embolism) or history within 1 year prior to enrollment.

12. History of GI perforation and/or serious abdominal fistula within 1 year prior to enrollment

13. Cases that the investigator judged as inappropriate as the subject of this clinical study

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chugai Pharmaceutical

INDUSTRY

Sponsor Role: collaborator

Japan Breast Cancer Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Masakazu Toi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kyoto University, Graduate School of Medicine

Shigehira Saji, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fukushima Medical University

Locations

Japan Breast Cancer Research Group

Chuo-ku, Nihonbashi, Koami-cho, Tokyo, Japan

Countries

Japan

References

Saji S, Taira N, Kitada M, Takano T, Takada M, Ohtake T, Toyama T, Kikawa Y, Hasegawa Y, Fujisawa T, Kashiwaba M, Ishida T, Nakamura R, Yamamoto Y, Toh U, Iwata H, Masuda N, Morita S, Ohno S, Toi M. Switch maintenance endocrine therapy plus bevacizumab after bevacizumab plus paclitaxel in advanced or metastatic oestrogen receptor-positive, HER2-negative breast cancer (BOOSTER): a randomised, open-label, phase 2 trial. Lancet Oncol. 2022 May;23(5):636-649. doi: 10.1016/S1470-2045(22)00196-6. Epub 2022 Apr 8.

Reference Type: DERIVED

PMID: 35405087 (View on PubMed)

Other Identifiers

UMIN000012179

Identifier Type: REGISTRY

Identifier Source: secondary_id

JBCRG-M04

Identifier Type: -

Identifier Source: org_study_id