NOLAN: Naproxen or Loratadine and Neulasta

Amgen

Status and phase: Completed; Phase 2

Conditions: Bone Pain in Stage I - III Breast Cancer

Treatments: Drug: Chemotherapy; Drug: Loratadine; Drug: Naproxen; Biological: Pegfilgrastim

Study type: Interventional

Funder types: Industry

Identifiers

NCT01712009

20110147

Details and patient eligibility

About

The primary objective of the study is to estimate the difference in bone pain between breast cancer patients receiving chemotherapy and pegfilgrastim and either no prophylactic intervention, prophylactic naproxen, or prophylactic loratadine.

Full description

In this study, the investigational products are naproxen, a non-steroidal antiinflammatory drug (NSAID), and loratadine, an anti-histamine. Both agents are being investigated as prophylactic medications to reduce the incidence and/or severity of bone pain in breast cancer patients receiving adjuvant or neoadjuvant myelosuppressive chemotherapy and pegfilgrastim prophylaxis.

Pegfilgrastim treatment is used to stimulate bone marrow to produce more neutrophils to help fight infections in patients undergoing chemotherapy.

Enrollment: 600 patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Age 18 years or over

• Eastern cooperative oncology group (ECOG) performance status 0-2
• Female with newly diagnosed, not previously treated with chemotherapy, stage I-III breast cancer
• Medically eligible to safely receive adjuvant or neoadjuvant chemotherapy, pegfilgrastim, naproxen and loratadine as determined by the investigator
• Creatinine ≤ 1.5 X upper limit of normal (ULN)
• Planning to receive at least 4 cycles of adjuvant or neoadjuvant chemotherapy
• Planning to receive prophylaxis with pegfilgrastim starting in the first cycle and continuing throughout each chemotherapy cycle of the treatment period
• Subject has provided informed consent

Exclusion Criteria

• History of other malignancy within the past 5 years, with the following exceptions:

  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  • Adequately treated cervical carcinoma in situ without evidence of disease

• Planning to receive weekly chemotherapy

• Ongoing chronic pain, or other painful conditions requiring treatment (including immediate post-operative treatment of surgical or procedural-associated pain) as determined by the investigator

• Chronic oral steroid use. Premedication related to the administration of chemotherapy, and use of anti-emetics is allowed, per usual clinical practice

• Chronic use of oral non-steroidal anti-inflammatory drug (NSAIDs) or oral antihistamines outside of those dictated by the randomization groups outlined in the protocol, with the following exception:

  • Chronic oral aspirin use for cardiovascular-related indications

• Prior chemotherapy treatment for cancer within 5 years of current breast cancer diagnosis

• Prior use of granulocyte colony stimulating factor (G-CSF)

• History of clinically significant gastrointestinal (GI) bleeding, history of GI ulcers or active GI bleeding within 6 months prior to randomization

• History of clinically significant bleeding disorders, thromboembolism within 6 months prior to randomization

• Currently enrolled in, or less than 30 days since ending, another clinical trial which includes language directing G-CSF (filgrastim, pegfilgrastim, other) or granulocyte-macrophage colony-stimulating factor (GM-CSF) (sargramostim) use

• Currently enrolled in, or less than 30 days since ending, another interventional clinical trial which includes a blinded treatment or blinded treatment arm (whether or not the subject is randomized to the blinded arm)

• Currently enrolled in, or less than 30 days since ending, another interventional clinical trial which includes the use of any agent not currently considered to be standard therapy for the adjuvant or neoadjuvant treatment of stage I-III breast cancer based on National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Breast Cancer

• Currently enrolled in, or less than 30 days since ending, any pain intervention study

• Female subjects who are pregnant or lactating or of reproductive potential not willing to employ an effective method of birth control during treatment and for 17 days after discontinuing study treatment

• History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Amgen, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 3 patient groups

Prophylactic naproxen

Experimental group

Description:

Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.

Treatment:

Biological: Pegfilgrastim

Drug: Naproxen

Drug: Chemotherapy

Prophylactic loratadine

Experimental group

Description:

Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.

Treatment:

Biological: Pegfilgrastim

Drug: Chemotherapy

Drug: Loratadine

No prophylactic treatment

Other group

Description:

Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis.

Treatment:

Biological: Pegfilgrastim

Drug: Chemotherapy