A study comparing capecitabine with megestrol acetate or placebo in patients with hormone receptor-positive, HER2-negative metastatic breast cancer (CAMEO Study)

A placebo-controlled, randomised phase III trial comparing capecitabine with megestrol acetate or capecitabine with placebo in hormone receptor-positive and HER2-negative metastatic breast cancer (CAMEO Study) - CAMEO Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/094986

Enrollment

366

Registered

2025-09-17

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C508- Malignant neoplasm of overlappingsites of breast

Interventions

Intervention1: Capecitabine with Megestrol Acetate: Arm A (Experimental Group): Megestrol acetate (MA) 160 mg per oral (PO) once a day (OD) with capecitabine 1000 mg/m2 PO BD for 2 weeks with 1 week o

Eligibility

Inclusion criteria

Inclusion criteria: Age 18 and above years. Post-menopausal women or pre-menopausal women on ovarian suppression Histologically proven breast cancer: In advanced or metastatic stage HR positive either estrogen receptor positive and/or progesterone receptor positive as per ASCO-CAP guidelines HER2 negative defined as IHC 2 positive/ISH negative or IHC 0 and 1 positive. Received at least two lines of endocrine-based therapy for advanced or metastatic disease or had cancer progression while undergoing adjuvant endocrine therapy or within 12 months of completion of adjuvant endocrine therapy. Prior CDK4 or 6 inhibitor is mandatory. Have received no prior line of chemotherapy in the metastatic setting. ECOG PS less than 2.

Exclusion criteria

Exclusion criteria: Contraindication to capecitabine. Patients with prior megestrol acetate or current exposure to natural/synthetic progesterone compounds. Patients with uncontrolled brain metastases. Patients with a history of venous thromboembolism or known thrombophilia

Design outcomes

Primary

Measure	Time frame
To compare progression-free survival (PFS) between patients receiving capecitabine with Megestrol acetate (MA) versus capecitabine with placebo (Identical in appearance with Megestrol acetate )Timepoint: PFS (time from randomisation until disease progression per RECIST 1.1 or death, whichever occurs first)	—

Secondary

Measure	Time frame
To compare the 2 groups for: Overall Survival (OS) between both arms, Tumour response rates in patients with measurable disease (ORR), Clinical Benefit Rate (CBR), Safety (side effects), Quality of Life (QOL).Timepoint: OS: Survival follow-up every 3 months after progression until death ORR:Tumour assessment every 12 1 weeks until progression CBR:Tumour assessment every 12 1 weeks until progression, QoL:At baseline, then every 12 weeks during treatment, & at treatment discontinuation	—

Measure

Time frame

To compare the 2 groups for: Overall Survival (OS) between both arms, Tumour response rates in patients with measurable disease (ORR), Clinical Benefit Rate (CBR), Safety (side effects), Quality of Life (QOL).Timepoint: OS: Survival follow-up every 3 months after progression until death ORR:Tumour assessment every 12 1 weeks until progression CBR:Tumour assessment every 12 1 weeks until progression, QoL:At baseline, then every 12 weeks during treatment, & at treatment discontinuation

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Countries

India

Contacts

Public ContactDr Anuradha Mehta

Tata Memorial Hospital

anuradhamehta1911@gmail.com9953532070

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026