Evaluation of Oral Care to Prevent Oral Mucositis in ER Positive MBC Patients Treated With Everolimus: Phase 3 RCT

NCT02376985 | Completed Phase 3 DMC

• 1 other identifier: Oral Care-BC
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

To examine whether the occurrence of oral mucositis can be reduced by dental oral management in patients by comparing the use of dental oral management through instruction by dental and oral surgeons (dental oral management group) and an observation group (brushing instruction only group) in a randomized, controlled study in females that are using everolimus for estrogen receptor-positive, hormone therapy-resistant refractory breast cancer.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of oral mucositis (Over Grade 1) after everolimus treatment

  Incidence of oral mucositis in Grade 1 or more, is evaluated by an oncologist.

  Patients are followed up for 8 weeks after initial enrollment

Secondary Outcomes (10)

• Incidence of oral mucositis (Over Grade 2)

  Patients are followed up for 8 weeks after initial enrollment

• Incidence of oral mucositis (Over Grade 3)

  Patients are followed up for 8 weeks after initial enrollment

• Incidence of oral mucositis (Over Grade 1)

  Patients are followed up for 8 weeks after initial enrollment

• Incidence of oral mucositis (Over Grade 2)

  Patients are followed up for 8 weeks after initial enrollment

• Incidence of oral mucositis (Over Grade 3)

  Patients are followed up for 8 weeks after initial enrollment

Study Arms (2)

Brushing instruction group

PLACEBO COMPARATOR

Drug: Everolimus and Exemestane Everolimus, 10 mg/day Exemestane, 25 mg/day Administration on consecutive days once daily after breakfast until tumor progression or for a minimum 8 weeks. Oral treatment: Brushing and gargling with saline after every meal (initially instructed by a dental/oral surgeon).

Drug: Everolimus

Dental oral management group

EXPERIMENTAL

Drug: Everolimus and Exemestane Everolimus, 10 mg/day Exemestane, 25 mg/day Administration on consecutive days once daily after breakfast until tumor progression or for a minimum 8 weeks. Oral treatment: Scaling and enamel polishing will be performed by a dental and oral surgeon or dental hygienist before everolimus treatment, and once weekly after everolimus treatment. Brushing and gargling with Neostelin Green 0.2% mouthwash solution after every meal (initially instructed by a dental/oral surgeon).

Procedure: Oral management; Drug: Everolimus

Interventions

Oral management PROCEDURE

Dental oral management group

Everolimus DRUG

Brushing instruction group; Dental oral management group

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients with a histological diagnosis of breast cancer (regardless of histological subtype of breast cancer).
• Diagnosis of metastatic or recurrent breast cancer satisfies either of the below.
• Distant metastasis present that is inoperable at time of first examination (Stage IV, 3.1 Clinical stage classification)
• Progression of distant metastasis or recurrence of breast cancer after treatment (after surgery and after treatments prior to and after surgery)
• Histologically confirmed diagnosis of ER-positive breast cancer
• Postmenopause
• Any of the below conditions indicating resistance to aromatase inhibitor therapy. The aromatase inhibitor therapy need not be the most recent therapy.
• Recurrence during ongoing adjuvant therapy with an aromatase inhibitor, or recurrence within 12 months after adjuvant therapy with an aromatase inhibitor
• Progression during ongoing aromatase inhibitor therapy for advanced breast cancer, or progression within 1 month after ending aromatase inhibitor therapy
• Any number of chemotherapy (anti-neoplastic drugs) are allowed since diagnosis of metastatic or recurrent breast cancer
• Aged ≥20 years
• PS of 0-1. (ECOG scale).
• Previous treatment (including adjuvant therapy) satisfies all the conditions below.
• Hormone therapy: At least 7 days have elapsed from the last administration of hormonal therapy.
• Radiotherapy: At least 14 days have elapsed from the last irradiation.

You may not qualify if:

• Edentulous jaw (in both upper and lower jaws)
• Occurrence of oral mucositis within 1 month prior to randomization
• Chemotherapy used within 1 month prior to randomization
• Previous mTOR inhibitor treatment (everolimus, etc.)
• Interstitial pneumonia or pulmonary fibrosis.
• Received drug treatment known to have a strong inhibitory or inductive effect on the cytochrome P450 (CYP) 3A isozymes (rifabutin, rifampicin, clarithromycin, ketoconazole, itraconazole, voriconazole, ritonavir, telithromycin) (See Table 4.1.2.1 and 4.1.2.2 for lists of prohibited concomitant drugs).
• Positive result of HBs antigen, HBc antibody and/or HBs antibody.
• HCV infection or a history of HCV infection.
• History of hypersensitivity to a protocol treatment drug or a vehicle in the drug preparation.
• Multiple active cancers (homochronous multiple cancers, or heterochronous multiple cancers with a cancer-free period of less than 5 years prior to randomization).
• Carcinoma in situ deemed to be cured by local treatment (lesions that are intraepithelial carcinoma or mucosal cancer) is not included as an active multiple cancer.
• Overexpression of HER2 (Her2/neu, Erb B2), and the condition is considered to be indicated for trastuzumab (herceptin®) treatment (when the state of HER2 expression is unknown, the patient is not excluded, but is treated as eligible).
• In other words, patients that satisfy any of the below conditions will be excluded.
• At either the primary or the metastatic lesion:
• Strongly positive, "3+" by HER2 IHC.

Sponsors & Collaborators

• Comprehensive Support Project for Oncology Research: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Tokai University, School of Medicine

Isehara, Kanagawa, 259-1193, Japan

Location

Related Publications (1)

• Nakatsukasa K, Niikura N, Kashiwabara K, Amemiya T, Watanabe KI, Hata H, Kikawa Y, Taniike N, Yamanaka T, Mitsunaga S, Nakagami K, Adachi M, Kondo N, Shibuya Y, Hayashi N, Naito M, Yamashita T, Umeda M, Mukai H, Ota Y. Secondary endpoints analysis in patients with estrogen receptor-positive metastatic breast cancer treated with everolimus and exemestane enrolled in Oral Care-BC. BMC Cancer. 2021 Jan 7;21(1):34. doi: 10.1186/s12885-020-07746-9.

  PMID: 33413212 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Therapeutics; Everolimus

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Akira Yamao

  Public Health Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 3, 2015
• Study Start: March 26, 2015
• Primary Completion: March 31, 2018
• Study Completion: October 16, 2018
• Last Updated: October 21, 2019

Record last verified: 2019-07

Locations

JP (1)